ICS 27.120.01 
F 54 
NATIONAL STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA 
GB 13172-20xx 
  Replaces GB 13172-91 
 
    
 
   
 
    
 
 
Molybdenum 99 – technetium 99m chro matographic generator (fission) 
 
(Draft Submitted for Approval) 
 
(This draft completed on: 29 April 2008) 
 
    
 
    
 
        Announced XX-XX-20XX   Effective XX-XX-20XX
 Announced by: 
General Administration of Quality Supervis ion, Inspection and Quarantine of the 
People's Republic of China   
GB 13172-20xx 
 
Table of Contents 
 
1 Scope 1 
2 Cited regulatory documents 1 3 Terms and definitions 1 
4 Product specifications 2 
5 Technical requirements 2 
6 Test methods 2 
7 Inspection rules 3 
8 Product marks, labels and instructions for use 4 9 Packaging, transportation and storage 4    
 
        
 
         
 
        
 
        
I GB 13172-20xx 
 
Foreword 
 
 The present standard is a revision of GB 13172-91 “99Mo-99mTc chromatographic generato r (fission).” The present 
standard replaces GB 13172-91 “99Mo-99mTc chromatographic generator (fission)” upon announcement. The present standard 
changes GB 13172-91 primarily with respect to the following:  a) revises the standard title;  b) adds five cited regulatory docume nts including GB 2828 “Sampling procedures and tables for lot-by-lot inspection 
and counting” and EJ/T 843-94 “Radionuclide activity me asurement—Well-type ioniza tion chamber method;” 
 c) changes “test” and “determination” in  the former document to “inspection;” 
 d) deletes article 3.3 of the former standard and adds such terms as “eluant,” “eluat e,” “calibration time,” and 
“aluminium content;”  e) changes “sodium chloride injection” of the former standard to “ eluant;” 
 f) deletes Chapter 4 of the former standard; 
 g) adds new product specifications;  h) deletes 6.1.1 and 6.1.4 of the former standard;  i) adds technical requirements relating to generator surface radioactive contamination; 
 j) adjusts 6.2.9 of the former standard to technical requirements for the generator; 
 k) deletes article 7.2 of  the former standards; 
 l) adds an inspection rules chapter;  m) splits chapter 8 of the former standard into two chapte rs: “Marks, labels and instruct ions for use” and “Packaging, 
transportation and storage;”  n) revises some of the language of the former standard. 
 The present standard was put forward by, and is under the jurisdiction of, the Radioact ive Isotopes Technical Sub-
committee of the National Nuclear Energy Standardisation Technical Committee.  The entity that drafted the present st andard: China Institute of Atomic Energy 
 Authors of the present standard: Niu Xuxiang, Chen Daming, Liu Guangyu  The present standard was first announced on 29 October 1991.     
 
         
 
       
II 
  
GB 13172-20xx 
 
Molybdenum 99 – technetium 99m chromatographic generator (fission) 
 
1 Scope 
 
 The present standard specifies the technical requirements,  testing methods, inspection  rules, marks, inspection 
certificates, instructions for use, packaging, transportation , and storage for molybdenum 99-technetium 99m chromatographic 
generators (fission). 
The present standard applies to medical molybdenum 99- technetium 99m chromatogra phic generators which use 
Al2O3 as an adsorbent. It does not apply to other types of techne tium 99m generators. 
 2 Cited regulatory documents 
 
 The clauses in the documents below become clauses of the present standard by virtue of being cited by the present 
standard. If a date is indicated for a cited document, no s ubsequent revision sheet (not including corrigenda) or amended 
version shall apply to the present standard. Nevertheless, th e parties to agreements based on the present standard are 
encouraged to study whether the most recent versions of thes e documents can be used. If no date is indicated for a cited 
document, then the most recent version applies to the present standard.  GB 11806  Regulations for the safe transport of radioactive material 
 People’s Republic of China Phar macopoeia, Part 2 (2005 edition) 
 GB 2828  Sampling procedures and tables  for lot-by-lot inspection and counting 
 EJ/T 843-1994  Radionuclide activity measurem ent—Well-type ionizati on chamber method 
 EJ/T 845-1994 Methods of determining the pH of radiopharmaceuticals 
 GSYJZ [2006] No. 264 “Detailed standard fo r radiopharmaceutical package inserts” 
 3 Terms and definitions   The following terms and definition s apply to the present standard. 
 3.1  molybdenum 99-technetium 99m ch romatographic generator (fission) 
 Refers to a device that adsorbs fission molybdenum 99 to an Al
2O3 chromatographic column from which, as 
appropriate, the daughter nuclide techne tium 99m, a decay product of molybdenu m 99, may be eluted with an eluent. 
3.2  eluent  The solution that is used to elute technetium 99m from th e generator. In the present stan dard, it especially refers to 
sodium chloride injection. 3.3  eluate  The technetium 99m-containing solution that is eluted from the generator using eluent. 
3.4 
 calibration time 
 The time corresponding to the product specification. 3.5  aluminium concentration  Aluminium content in unit vo lume eluate; unit is µg/mL. 
3.6  elution efficiency  
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GB 13172-20xx 
 
 The ratio in percentage terms of the acti vity of technetium 99m eluted using a ce rtain volume of eluant to the activity 
of technetium 99m present in the ge nerator at the start of elution. 
 4 Product specifications   The product has the following specifications:   11.1 GBq; 18.5 GBq; 29.6 GBq; 37 GBq, and above 37 GBq.  
5 Technical requirements 
 5.1 Technical requirements of the generator 5.1.1 Elution efficiency  Elution efficiency for 10 mL eluant shall be at least 90%. 5.1.2 Surface radioactive contamination  Radioactive contamination of the genera tor surface shall be less than 0.4 Bq/cm
2. 
5.1.3 Expiration date  The expiration date of this pr oduct is 15 days after production. 
5.2 Eluant technical requirements 
5.2.1 Appearance  Shall be a colourless, clear liquid. 5.2.2 pH  Shall be between 4.0 and 7.0. 5.2.3 Aluminium content  Shall be no greater than 10 µg/mL. 5.2.4 Radionuclide purity  Radioactive impurity activity relative to total radi oactivity shall not exceed the specifications below: 
99M o      1  ×  1 0-1% 
131I      5  ×  1 0-3% 
103R u      5  ×  1 0-3% 
89S r      6  ×  1 0-5% 
90S r      6  ×  1 0-6%  
 α impure nuclide    1 x 10-7% 
 other total β and γ nuclides   1 x 10-2% 
5.2.5 Radiochemical purity  The content of N
a99mTcO 4 shall be at least 98%. 
5.2.6 Activity  The 
99mTc eluted from the generator shall, calculated accordin g to the calibration time, be 90.0% to 110.0% of the 
nominal quantity. 5.2.7 Bacterial endotoxins 
 Shall comply with the specificatio ns of People’s Republic of China Pharmacopoeia, Part 2 (2005 edition). 
5.2.8 Sterility  Shall comply with the specificatio ns of People’s Republic of China Pharmacopoeia, Part 2 (2005 edition). 
 6 Inspection methods  6.1 Generator inspection 6.1.1 Elution efficiency  In accordance with the calibration time and product specifications, calculate the activity A
1 of 99mTc in the generator 
at elution. Using 10 mL eluant to elut e the generator, determine the activity A2 of 99mTc in the eluate. Use the formula below to 
calculate elution efficiency η: 
 
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GB 13172-20xx 
 
 Where: 
 η—elution efficiency, unit is %; 
 A 1—activity of 99mTc in the generator at elution, unit is Bq; 
 A 2—activity of 99mTc in eluate, unit is Bq. 
6.1.2 Surface radioactive contamination  Test using the wipe method. 6.1.3 Expiration date  Conduct inspection on each technica l requirement for the generator within  15 days from the production date. 
6.2 Eluate inspection 6.2.1 Appearance  Inspect with the naked eye after placing a vial f illed with 1 mL eluate behind a lead glass shield. 
6.2.2 pH 
 Test in accordance with the method specified in EJ/T 845-94. 
6.2.3 Aluminium content  Measure in accordance with the spec ifications of the People 's Republic of China Pharmacopoeia, Part 2 (2005 
edition). 6.2.4 Radionuclide purity  Take an appropriate quantity of eluate, meas ure the amount of radioactive impurity with a γ-spectrum 
spectrometer, calculate the ratio of impure nuclide ac tivity to total activity in percentage terms. 
6.2.5 Radiochemical purity  Test in accordance with method 1 in People’s Republic of China Ph armacopoeia, Part 2 (2005 edition), 
Appendix XIII. 
6.2.6 Activity  Elute the generator with 10 mL eluant. Collect the eluate, and measure in accordance with the method 
specified in EJ/T 843-94. 6.2.7 Bacterial endotoxins  Take an appropriate quantity of eluate. Dilute 15 : 1 with water used for bacterial endotoxin examinations. 
Inspect in accordance with method E in  the People’s Republic of China Pharmacopo eia, Part 2 (2005 edition), Appendix XI. 
6.2.8 Sterility  Inspect in accordance with method H in the People’s Republic of China Pharmacopoeia, Part 2 (2005 edition), 
Appendix XI. 
 
7 Inspection rules  7.1 Comprehensive inspection  All items specified in the technical requirements of  the present standard constitute the comprehensive 
inspection. Comprehensive inspections shall involve at leas t three samples and be conducted biannually. A comprehensive 
inspection shall also be conducted in  the event of any of the following: 
 a) when the raw materials, structur e, or production proce ss of the generator undergo es a relatively major 
change which might affect product quality; 
 b) when production is restored after being suspended for more than one year; 
 c) when a quality supervision department of the state requests a comprehensive inspection. 
7.2 Pre-shipment inspection 7.2.1 The pre-shipment inspection shall make use of sa mpling. The sampling procedures and quantities shall be 
determined in accordance with the specifications of GB 2828. 
7.2.2 Generator pre-shipment inspection items are as follows:  a) radioactivity;  b) surface radioactive contamination. 7.2.3 Eluate pre-shipment insp ection items are as follows: 
 a) appearance; 
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GB 13172-20xx 
 
 b) pH; 
 c) aluminium content;  d) radionuclide purity;  e) radiochemical purity;  f) activity;  g) bacterial endotoxins;  h) sterility. 8 Product marks, labels and instructions for use  
8.1 Marks 
 The outer package of the generation  shall have the marks listed below: 
 a) radioactivity mark;  b) radioactive transportation category mark;  c) “Keep out of rain,” “Handle with care,” and “This side up” marks. 8.2 Labels  Labels are divided into inner package and outer package labels. Inner package labels are attached to the surface 
of the generator. Outer package labels ar e attached to the outer package. Labels shall include the following information: 
 a) product name; 
 b) radioactivity mark; 
 c) approval document number;  d) specification;  e) product lot number;  f) radioactivity;  g) calibration time;  h) expiration date;  i) manufacturer. 8.3 Instructions for use  Generators shall be provided with instructions for use when shipped from the factory. The contents of 
instructions for use shall comply with the provisions of GSYJZ [2006] No. 264. 
 9 Packaging, transportation and storage  9.1 Packaging  Product packaging, in an inside-to-outside sequence, shall consist of: lead cylinder, foam padding, and iron-
sheet drum. The radioactive contamination level and radiation le vel of the outer package container surface shall comply with 
the provisions of GB 11806.  When packaging, enclose the instructions for use in th e iron-sheet drum. Seal with lead after packaging is 
completed. 
9.2 Transportation  Products shall be shipped in accord ance with the provisions of GB 11806. 
9.3 Storage  The product shall be kept at a constant temperature in a clean environment. Please be sure to protect against 
theft, freezing, tipping  over, and vibrations. 
    
 
 
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