SUPPLY AGREEMENT

 
THIS SUPPLY AGREEMENT (hereinafter "Agreement") is made this 28th day of June,
2008, by and between InovaChem Inc., a Delaware corporation, with headquarters
at 3040 Post Oak Blvd, Suite 1110, Houston, Texas 77056, USA (hereinafter
“InovaChem”), and Polymed Therapeutics Inc., a Texas corporation, with
headquarters at 3040 Post Oak Blvd, Suite 1110, Houston, Texas 77056, USA
(hereinafter “Polymed”).
 
RECITALS

 
A.
InovaChem owns the Intellectual Property (as defined below), which relates to
the manufacture of sucralose.

 
B.
Polymed manufactures food and pharmaceutical ingredients for use in products
similar to sucralose.

 

 
C.
InovaChem and Polymed desire that Polymed manufacture sucralose exclusivelyfor
InovaChem on the terms and conditions set forth in this Agreement.

 
AGREEMENT

In consideration of the premises, and for other good and valuable consideration,
the receipt and sufficiency of which hereby are acknowledged, the parties hereby
agree as follows:

1. Definitions. In this Agreement the following terms shall have the following
meanings whenever such terms are used:

(a) “Cost Price” shall mean the cost of manufacturing the Product as set forth
on Schedule A attached hereto.
 
(b) “Intellectual Property” shall mean any and all patent, patent application
and other patent right, copyright, trademark, and tradename owned by or licensed
to InovaChem, its subsidiaries and affiliates, including but not limited to
those set forth on Schedule B attached hereto.

(c) “Product” shall mean sucralose and sucralose products manufactured in
accordance with the Intellectual Property.

(d)  “Regulations” shall mean any and all Federal and State laws, including
without limitation, the regulations, policies and guidelines promulgated by the
U.S. Food and Drug Administration and other applicable regulatory authorities,
with respect to the manufacturing and testing practices for products similar to
the Product.

1

--------------------------------------------------------------------------------

 
(e)  “Specifications” shall mean the technical specifications for the
manufacture of the Product as set forth on Schedule C attached hereto.

2. Term. This Agreement shall be effective from the date first set forth above
(the “Effective Date”). The term of this Agreement shall be for a period of
thirty-six (36) months from the Effective Date. This Agreement shall
automatically renew for successive twelve (12) month periods, unless a party
provides notice to the other party within ninety (90) days prior to the
expiration of the term of this Agreement, as such term may have been extended,
that such party does not wish to extend the term of this Agreement. This
Agreement may also be terminated by either party upon ninety (90) days prior
written notice to the other party.

3. Purchase Orders; Delivery of Product.

(a)  Polymed shall manufacture the Product pursuant to the Specifications and in
accordance with the Intellectual Property, and deliver to InovaChem the Product
in such quantities as InovaChem may order from time to time pursuant to one or
more purchase orders (each a “Purchase Order”) in accordance with the terms of
this Agreement. Each Purchase Order will set forth the Product ordered, the
quantity of such Product and the Purchase Price for the Product calculated in
accordance with Schedule A. The delivery date for the Product will be sixty (60)
days from the date of the Purchase Order. Polymed shall promptly notify
InovaChem of any change in the lead time. Polymed shall confirm in writing its
acceptance of each Purchase Order upon receipt of such Purchase Order. Delivery
for all Products will be F.O.B. ex-factory. InovaChem shall be responsible for
all costs associated with transporting and importing the Product, including,
without limitation, freight fees, insurance, taxes, customs, duties, licenses,
permits and other governmental fees required to deliver the Product to the
destination of InovaChem’s choice. In January of each year, InovaChem shall
provide a forecast of the quantity of Product InovaChem anticipates purchasing
during such year. Such forecast shall not bind InovaChem to order the forecasted
amount during such year.

(b) The parties acknowledge that the Product to be manufactured and delivered
pursuant to the Purchase Orders shall not be sold directly to consumers at this
time. If at any time in the future, Product delivered pursuant to any Purchase
Order is to be sold directly to consumers, InovaChem shall identify that such
Product is for sale to consumers on the Purchase Order and provide the
appropriate labeling and packaging for such Product that complies in all
respects with the Regulations.

4.  Price: Payment. InovaChem shall purchase the Product from Polymed for the
Cost Price plus fifteen (15%) percent (the “Purchase Price”). Payment terms
shall be net thirty (30) days from shipment of the Product by Polymed. Payment
will be made by bank wire transfer pursuant to the wire transfer instructions
Polymed provides. Polymed shall invoice InovaChem for Product on a monthly
basis. The invoice shall be calculated in accordance with Schedule A and shall
be subject to Financial Audit (as defined below) by Inovachem in accordance with
this Agreement.

2

--------------------------------------------------------------------------------

 
5. Confidentiality. (a) The term “Confidential Information” means all products,
services, systems, technology, designs, devices, processes, plans, ideas,
innovations, knowledge, know-how, diagrams, directions, specifications, models,
formulae, discoveries, developments, modifications, data and other information
relating to, owned or used by InovaChem or any parent, subsidiary or affiliate
of InovaChem, or to any business in which InovaChem, or any parent, subsidiary
or affiliate of InovaChem is engaged or contemplates becoming engaged; all
business plans, development plans, site plans, architectural and engineering
plans, marketing plans, marketing strategies, existing and prospective customer
lists and information of InovaChem or any parent, subsidiary or affiliate of
InovaChem, or relating to any business in which InovaChem, or any parent,
subsidiary or affiliate of InovaChem is engaged or contemplates becoming
engaged; all information or data supplied by or concerning InovaChem, or any
parent, subsidiary or affiliate of InovaChem, or any client, equity partner,
lender or customer of any of the foregoing or any business in which any such
clients, equity partner, lender or customers are engaged or contemplate becoming
engaged; and all trade secrets and confidential information belonging to
InovaChem or any parent, subsidiary or affiliate of InovaChem. In addition,
Confidential Information shall include all Intellectual Property, including
without limitation any and all patent, patent application, patent right, and all
improvements and enhancements thereto (as set forth on Schedule B), owned or
developed by InovaChem, or any parent, subsidiary or affiliate of InovaChem, or
any employee, contractor, consultant, agent or licensee/licensor of any of the
foregoing. Confidential information shall not belong to or be deemed to be in
the public domain merely as a result of such Confidential Information being in
the prior possession of Polymed.

(b) As a consequence of the parties’ relationship with each other, Polymed will
receive and deal with Confidential Information belonging to InovaChem. Polymed
further acknowledges that Confidential Information to be received or dealt with
by it is of such a value and nature to InovaChem, and/or protected from
disclosure by Regulations, as to make it reasonable and necessary for the
protection and non-disclosure of the Confidential Information to any third
party, and that InovaChem will be irreparably damaged if Polymed were to
disclose any of the Confidential Information that it receives or deals with.
Polymed acknowledges and agrees that all Confidential Information regarding
InovaChem or its parents, subsidiaries or affiliates which is compiled or
obtained by Polymed or furnished to it in connection with the parties’
relationship is InovaChem’s exclusive property, and that said Confidential
Information shall not be disclosed to any person, firm or entity, any time
during or after the term of this Agreement, except as required to perform the
transaction contemplated by this Agreement. Polymed agrees and acknowledges that
it shall have no right, title or interest in the Confidential Information
belonging to InovaChem. Polymed recognizes that, notwithstanding the provisions
of this Agreement, InovaChem may legitimately refuse to disclose, or may defer
disclosure of, certain Confidential Information to the extent that it is not
necessary for the purpose of this Agreement. Upon demand by InovaChem, and in
any event within three (3) days following the termination of this Agreement,
Polymed will surrender to InovaChem all Confidential Information and all other
original and facsimile records, documents and data in Polymed’s possession or
control pertaining to or belonging to InovaChem.

3

--------------------------------------------------------------------------------

 
(c) In the event that Polymed is requested or required (by deposition,
interrogatories, requests for information or documents in legal, regulatory or
administrative proceedings, subpoenas, civil investigative demand or similar
process), in connection with any proceeding, to disclose any Confidential
Information belonging to InovaChem, Polymed will give InovaChem prompt written
notice of such request or requirement so that InovaChem may seek an appropriate
protective order or other remedy and/or waive compliance with the provisions of
this Agreement, and Polymed will cooperate with InovaChem to obtain such
protective order or remedy. In the event that such protective order or other
remedy is not obtained or InovaChem waives compliance with the relevant
provisions of this Agreement, Polymed will furnish only that portion of the
Confidential Information which, in the opinion of its counsel, is legally
required to be disclosed and, will use its best efforts to obtain assurances
that confidential treatment will be accorded to such information.

6. Existing Intellectual Property. Polymed shall have no rights in and to the
Intellectual Property as a result of being a prior assignee of such Intellectual
Property. InovaChem shall retain all right, title and interest arising under the
United States Patent Act, the United States Trademark Act, the United States
Copyright Act and all other applicable Regulations relating to the Intellectual
Property, the Product, and any label, trademark or tradename associated
therewith (collectively, "InovaChem's Intellectual Property"). Neither Polymed
nor any third party shall acquire any right, title or interest in InovaChem's
Intellectual Property by virtue of this Agreement or otherwise, except to the
extent expressly provided herein.
 
7. Individually Owned Inventions. Except as the parties may otherwise agree in
writing, any Invention (as defined herein) which is conceived, reduced to
practice, or created by Polymed in the course of performing its obligations
under this Agreement as it relates to the Products and Intellectual Property
shall be solely owned by InovaChem, whether or not InovaChem is the inventing
party. Any and all use and exploitation of the Invention shall be solely at the
discretion of InovaChem. For purposes of this Agreement, "Invention" shall mean
any invention, innovation, improvement, development, discovery, computer
program, device, trade secret, method, know-how, process, technique or the like,
whether or not written or otherwise fixed in any form or medium, regardless of
the media on which contained and whether or not patentable or copyrightable.
Polymed shall assign, or cause to be assigned, to InovaChem all patent rights
and other intellectual property rights covering any Invention.
 
8. Exclusivity. Polymed shall manufacture the Product exclusively for InovaChem.
Polymed shall not manufacture, sell or otherwise supply Product or any other
sucralose-related product to any third party without the prior written consent
of InovaChem.

9. Specifications: Manufacturing process. Polymed shall manufacture the Product
in accordance with the Specifications and the manufacturing process of the
Intellectual Property. Polymed shall not modify or deviate from the
Specifications or the manufacturing process pursuant to the Intellectual
Property without the prior written consent of InovaChem.  Polymed shall test, or
cause to be tested, each batch of Product manufactured pursuant to this
Agreement before delivery to InovaChem to ensure the Product conforms with the
Specifications in all respects. A certificate of analysis for each batch of
Product will be delivered to InovaChem that sets forth the items tested and such
test results. Polymed shall send such certificate to InovaChem prior to or at
the time the Product is shipped to InovaChem. Polymed will obtain and maintain
all permits and licenses required for it to carry out its obligations pursuant
to this Agreement, and will comply with all applicable Regulations in connection
with manufacturing, handling, storage, distribution, and resale of any Product
delivered to InovaChem. Polymed may use subcontractors located in the People’s
Republic of China to fulfills its manufacturing obligations under this
Agreement; provided, however, that Polymed must obtain InovaChem’s prior written
consent of any subcontractor that Polymed seeks to use to manufacture the
Product in accordance with Section 21. Polymed shall maintain internal standard
operating procedures as to product recalls and the treatment of product
complaints and inquiries regarding safety, quality or efficacy that are in
keeping with accepted standards in the United States, and shall promptly notify
InovaChem of any issues associated with the Product of which Polymed becomes
aware.

4

--------------------------------------------------------------------------------

 
10. Warranties. Polymed represents and warrants to and covenants with InovaChem
that upon delivery, the Product shall conform to the Specifications in all
respects, and it shall have been manufactured in accordance with the
Intellectual Property. Polymed covenants that the Product will be manufactured
in accordance with all applicable Regulations, including applicable United
States Federal laws and regulations, and applicable regulations of the countries
where the Product may be sold or distributed. Polymed covenants that the Product
will be fit for consumption by humans and animals. EXCEPT AS EXPRESSLY SET FORTH
IN THIS AGREEMENT, POLYMED MAKES NO OTHER WARRANTIES, EXPRESSED OR IMPLIED, WITH
RESPECT TO PRODUCT, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY
OR FITNESS FOR A PARTICULAR PURPOSE. 

11.  Audit. (a) InovaChem shall have the right to visit and audit Polymed’s
manufacturing facilities to determine compliance with this Agreement and the
Regulations, and that the Product is being manufactured in accordance with the
Specifications and the manufacturing process pursuant to the Intellectual
Property. Such audits shall be scheduled at mutually agreeable times upon not
less than five (5) days written notice to Polymed, and shall be at InovaChem’s
expense. An audit may be made upon advance notice of less than five (5) days
upon a showing of good cause as a result of any quality issues of which
InovaChem may become aware.

(b) InovaChem shall have the right to conduct financial audits (hereinafter
“Financial Audit”) from time to time, in its sole discretion, and at its sole
cost (except as described below) to calculate the Cost Price. Polymed shall
provide all documents requested by InovaChem, including but not limited to, all
receipts, invoices, and accounting records of the costs comprising the Cost
Price as set forth in Schedule A. If such Financial Audit reveals that the Cost
Price was overstated by more than five percent (5%), then Polymed shall bear the
cost of the Financial Audit.
 
5

--------------------------------------------------------------------------------

 
12. Non-Conforming Product. If within ninety (90) days after accepting delivery
of any Product, InovaChem determines that all or any part of such Product was
non-conforming upon the date of delivery, InovaChem may reject such
non-conforming Product by giving written notice to Polymed. InovaChem shall
provide all analysis results with respect to such non-conforming Product to
Polymed. Polymed shall reimburse InovaChem for the amount of the Purchase Price
and all other costs paid by InovaChem in connection with such non-conforming
Product, including without limitation all freight and shipping charges and all
testing costs. Polymed shall use commercially reasonable efforts to replace
non-conforming Product with conforming Product promptly. In the event that
Polymed does not agree that such Product is non-conforming, Polymed, at it sole
expense, shall have the right to submit such Product to a third party
laboratory, mutually agreed to by the parties, for testing. The results of the
third party laboratory shall be binding upon the parties. If Product is
determined by the third party laboratory to be conforming, InovaChem shall
reimburse Polymed for the cost of testing the Product by the third party
laboratory.
 
13. Relationship of Parties. This Agreement shall not constitute or be construed
as creating a partnership or joint venture between InovaChem and Polymed, and
neither party shall be liable for any debts or obligations of the other party.
Neither party shall in any way be considered an agent or representative of the
other party in any dealings with any third party, and neither party may act for,
nor bind, the other party in any such dealings.

14. Indemnity. (a) Polymed shall indemnify, defend and hold harmless InovaChem,
and its subsidiaries, affiliates, successors and assigns and its and their
respective shareholders, members, managers, officers, directors, employees,
stockholders, agents and affiliates from and against any and all damages,
claims, losses, liabilities and expenses, including, without limitation, legal
fees and expenses, arising from, through or in any manner related to (i) any
breach by Polymed of its obligations under this Agreement; (ii) any act or
omission of Polymed or its employees, agents, independent contractors, invitees,
or licensees in connection with Polymed’s performance under this Agreement, and
(iii) liability for any premiums, taxes, or contributions of or with respect to
Polymed, and its employees, agents or independent contractors that may be
assessed against InovaChem.

(b) InovaChem shall indemnify, defend and hold harmless Polymed and its
affiliates, successors and assigns and its and their respective shareholders,
officers, directors, employees, stockholders, agents and affiliates from against
any and all damages, claims, losses, liabilities and expenses, including,
without limitation, legal fees and expenses, arising from, through or in any
manner related to (i) any breach by InovaChem of its obligations under this
Agreement; (ii) any liability arising out of or resulting from any Product that
complies with the Specifications and was manufactured pursuant to the
Intellectual Property unless such liability also results from a breach by
Polymed of its obligations under this Agreement; (iii) any liability arising out
of or resulting from InovaChem’s compliance or noncompliance with any
Regulation; and (iv) liability for any premiums, taxes, or contributions of or
with respect to InovaChem, and its employees, agents or independent contractors
that may be assessed against Polymed.

6

--------------------------------------------------------------------------------

 
15. Limitation of Liability. To the extent permitted under applicable
Regulations and except for a breach of Section 5, neither party shall be liable
to the other party for any special, consequential, exemplary or incidental
damages, arising from any claim relating to this Agreement, whether such claim
is based on contract, tort (including negligence) or otherwise, even if it has
been advised of the possibility or likelihood such damages. Notwithstanding the
foregoing, nothing in this section shall limit either party’s right to
indemnification for claims by third parties seeking any special, consequential,
exemplary or incidental damages.

16. Insurance Policies. InovaChem shall procure all insurance policies in
connection with the Product, including without limitation a policy covering
claims for product liability. Polymed shall be named as an additional insured on
any product liability insurance policy procured by InovaChem with respect to the
Product.

17. Notices. All notices, requests, consents and other communications required
or permitted under this Agreement shall be in writing and shall be deemed to
have been properly given (a) upon delivery, if delivered in person or by
facsimile transmission with receipt acknowledged by the recipient thereof, (b)
one business day after having been deposited for overnight delivery with any
reputable overnight courier service, or (c) three business days after having
been deposited in any post office or mail depository regularly maintained by the
U.S. Postal Service and sent by registered or certified mail, postage prepaid,
return receipt requested, addressed as follows:
 

If to InovaChem:
3040 Post Oak Blvd, Suite 1110,
Houston, Texas 77056, USA
 
Attention: Henry Toh
   
If to Polymed:
3040 Post Oak Blvd, Suite 1110,
Houston, Texas 77056, USA
 
Attention: William W. Zuo, PhD.

Any party hereto may change the address to which communications or copies are to
be sent to such party by giving notice of such change of address in conformity
with the provisions of this Section for the giving of notice.

18. No Waiver. The failure of either party to this Agreement to insist on the
performance of any of the terms and conditions of this Agreement, or the waiver
of any breach of any of the terms and conditions of this Agreement, shall not be
construed as a continuing waiver or as a waiver of any other terms and
conditions, but such terms and conditions shall continue and remain in full
force and effect as if no forbearance or waiver had occurred.

19.  Governing Law; Jurisdiction. This Agreement shall be governed by and
construed in accordance with the laws of the State of Texas without giving
effect to its conflicts of laws principles. Each party hereby irrevocably
submits to the exclusive jurisdiction of the courts of the State of Texas and
the United States District Court for the State of Texas, for the purpose of any
action or proceeding arising out of or relating to this Agreement and each party
hereby irrevocably agrees that all claims in respect of such action or
proceeding may be heard and determined exclusively in any Texas state or federal
court. Each party agrees that a final judgment in any action or proceeding shall
be conclusive and may be enforced in other jurisdictions by suit on the judgment
in any other matter provided by law.
 
7

--------------------------------------------------------------------------------

 
20. Partial Invalidity. If any one or more of the provisions contained in this
Agreement shall, for any reason, be held to be invalid, illegal or unenforceable
in any respect, this Agreement shall be reformed to eliminate such invalid,
illegal or unenforceable provisions and this Agreement shall be construed in an
enforceable manner that best achieves the parties’ intent in entering into this
Agreement.

21. Assignment; Binding Effect. Neither party may assign its rights or
obligations, in whole or in part, hereunder without the prior written consent of
the other party. Polymed may not subcontract any of its manufacturing
obligations hereunder without the prior written consent of InovaChem. Any
attempt to assign this Agreement without the prior written consent of the other
party shall be void. If InovaChem permits Polymed to delegate certain of its
obligations hereunder, at a minimum, Polymed (a) shall remain obligated to
InovaChem under this Agreement; (b) shall be liable for the performance of its
subcontractor; (c) shall indemnify InovaChem for any claims against InovaChem,
and/or its subsidiaries, affiliates, successors and assigns, and their
respective shareholders, members, managers, officers, directors, employees,
stockholders, agents and affiliates, as a result of the acts or omissions of its
subcontractor; and (d) shall assure that InovaChem has the right to inspect the
facilities of the subcontractor (similar to the inspection rights provided
hereunder), which facilities may be located in China. The terms of this
Agreement shall be binding on and inure to the benefit of the parties and their
respective permitted successors and permitted assigns.

22.  Modification Of Agreement. Any modification of this Agreement shall be in
writing signed by both parties hereto.

23. Survival Of Rights. The termination of this Agreement for any reason shall
be without prejudice to, and shall not affect, the right of each party to
recover from the other party any and all damages to which such party may be
entitled. In addition, any termination of this Agreement shall not release the
parties from liabilities and obligations accrued as of the date thereof.
Notwithstanding anything to the contrary that may be contained herein, in the
event of the termination or expiration of this Agreement, the idemnification and
confidentiality obligations contained herein shall survive such termination or
expiration.

24. Force Majeure. The parties shall not be liable for the failure or delay in
performing any obligation under this Agreement if and to the extent such failure
or delay is due to causes beyond the reasonable control of the affected party,
including a) acts of God, b) weather, fire or explosion, c) war, invasion, riot
or other civil unrest; d) changes in governmental laws, orders, restrictions,
actions, embargoes or blockages, e) national or regional emergency, f)
injunctions, strikes, lockouts, labor trouble or other industrial disturbances,
g) shortage of adequate fuel, power, materials or transportation facilities, or
h) or any other event which is beyond the reasonable control of the affected
party, provided that the party affected shall promptly notify the other as soon
as practicable, in writing, and in all events within ten (10) business days of
the force majeure condition, and shall be required to use its best efforts to
eliminate, cure or overcome any such causes and to resume performance of its
obligations as soon as possible.

8

--------------------------------------------------------------------------------

 
25. Entire Agreement. This Agreement embodies the entire agreement between the
parties with respect to the subject matter expressed herein and supersedes all
prior agreements, whether written or oral.

26. Counterparts. This Agreement may be executed in any number of counterparts,
each of which shall be deemed to be an original, but all of which together shall
constitute but one and the same instrument.

The parties hereto have caused this Agreement to be executed on the date first
written above.
 

InovaChem Inc.     Polymed Therapeutics Inc.         By: /s/ Henry Toh     By:
/s/ William W. Zuo

--------------------------------------------------------------------------------

Printed: Henry Toh
Title: Executive Vice President
   

--------------------------------------------------------------------------------

Printed: William W. Zuo, PhD.
Title: President

 
9

--------------------------------------------------------------------------------

SCHEDULE A

CALCULATION OF PRICE TO BE CHARGED BY POLYMED TO INOVACHEM

Definitions:

·  
Direct costs - labor, mechanical materials, packaging, raw materials (sugar,
solvents, chemicals - to be identified), and transportation.

·  
Indirect costs - utilities (water, electricity, steam, waste disposal) - at the
actual cost billed to Polymed and its affiliates with an allocation to Product
to be agreed upon by both parties based upon use of the applicable facilities to
manufacture Product versus use for other purposes.

·  
Overhead - Equipment depreciation, insurance, property taxes, and salaries (not
included in direct labor) with an allocation to Product to be agreed upon by
both parties based upon the overhead applicable to manufacture Product versus
use for other purposes.

Cost Price:

The Cost Price shall be the sum of all costs for the manufacture of Product,
which include direct costs, indirect costs, overhead and any other costs
directly attributable to manufacture of Product.

Calculation of the Cost Price shall be determined as follows:

1.  
Actual direct costs plus

2.  
Allocation of indirect costs using agreed upon percentages plus

3.  
Allocation of overhead using agreed upon percentages

Purchase Price: 

Total of Cost Price plus fifteen (15%) percent. Should the Purchase Price
calculated in accordance with this Schedule be greater than the global market
price of the Product, both parties shall negotiate and adjust the Purchase Price
accordingly, to a mutually agreeable price to both parties.

10

--------------------------------------------------------------------------------

SCHEDULE B

INTELLECTUAL PROPERTY

1.  
U.S. Patents Applications. 

  Application No. 11/898,652 - Novel Process for preparing sucrose 6-ester

 
Application No. 11/806,810 - Novel Chlorination process for preparing sucralose

 
Application No. 12/003,850 - CIP of 11/806,810

 
11

--------------------------------------------------------------------------------

 
SCHEDULE C

SPECIFICATIONS

SUCRALOSE (Product)

The Product shall be manufactured to meet either of the following
specifications, as stated in the certificate of analysis, and these criteria,
unless otherwise agreed to between the parties, shall be InovaChem’s criteria
for determining whether to accept Product:

Specification I:
United States Pharmacopeia, 30th Revision (Assay), 29th Revision (karl fisher),
28th Revision (Residue on Ignition)

Sucralose contains not less than 98.0 percent and not more than 102.0 percent of
C12H19Cl3O8, calculated on the anhydrous basis.
Identification— 
A: Infrared Absorption [Missing Graphic Reference]197K[Missing Graphic
Reference].
B: The retention time of the principal peak in the chromatogram of the Assay
preparation corresponds to that in the chromatogram of the Standard preparation,
as obtained in the Assay.
C: The RF value of the principal spot in the chromatogram of the Test solution
corresponds to that of Standard solution 1, as obtained in the test for Related
compounds.
Specific rotation [Missing Graphic Reference]781S[Missing Graphic Reference]:
between +84.0[Missing Graphic Reference] and +87.5[Missing Graphic Reference],
determined at 20[Missing Graphic Reference].
Test solution: 10 mg per mL, in water.
Water, Method I [Missing Graphic Reference]921[Missing Graphic Reference]: not
more than 2.0%.
Residue on ignition [Missing Graphic Reference]281[Missing Graphic Reference]:
not more than 0.7%.
Heavy metals, Method II [Missing Graphic Reference]231[Missing Graphic
Reference]: 0.001%.
Limit of hydrolysis products (0.1%).
Limit of methanol— not more than 0.1% of methanol is found.
Related compounds— (0.5%).

12

--------------------------------------------------------------------------------

 
Specification II:
Food Chemical Code, 5th Edition

Identification
A. The infrared absorption spectrum of a potassium bromide dispersion of the
sample exhibits relative maxima at the same wavelengths as those of a similar
preparation of Sucralose Standard for analytical use.1
B. The retention time of the major peak (excluding the solvent peak) in the
liquid chromatogram of the Sample Preparation is the same as that of the
Standard Preparation obtained in the Assay (below).
C. The Rf value of the major spot in the thin-layer chromatogram of the Test
Preparation is the same as that of the Standard Preparation obtained in the test
for Related Substances (below).
Assay Not less than 98.0% and not more than 102.0% of C12H19Cl3O8, calculated on
the anhydrous basis.
Hydrolysis Products Passes test.
Lead Not more than 1 mg/kg.
Methanol Not more than 0.1%.
Optical (Specific) Rotation [_]D 20°: Between +84.0° and +87.5°, calculated on
the anhydrous basis.
Related Substances Passes test.
Residue on Ignition Not more than 0.7%.
Water Not more than 2.0%.
 
13

--------------------------------------------------------------------------------