Chinese Pharmacopoeia Commission Consults on 46 Packaging Material Standards

by Grace Wang Jul 21, 2022

Since June 10, 2022, the Chinese Pharmacopoeia Commission has issued the drafts of 46 pharmaceutical packaging standards according to the plan for compiling the Chinese Pharmacopoeia 2025 Edition. The Commission is currently collecting public advice and comments on the drafts until Sept 1, 2022.

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The following is a list of the 46 pharmaceutical packaging material standards.

No.

Standard

1

9651 Guidelines on Biological Evaluation and Test Selection for Pharmaceutical Packaging Materials

2

9652 Guidelines on Inspections of Pharmaceutical Packaging Materials

3

5100 General Chapter on Glass Containers for Packaging Pharmaceuticals

4

5101 General Chapter on Glass Bottles for Infusion

5

5102 General Chapter on Glass Ampoules

6

5103 General Chapter on Glass Bottles for Injection

7

5104 General Chapter on Glass Components in Pencil Injectors

8

5105 General Chapter on Pharmaceutical Glass Bottles

9

4003 Determination of Internal Pressure of Glass Containers;

10

4017 Determination of Internal Pressure Resistance of Glass Containers

11

4018 Determination of Break Strength of Glass Ampoules

12

4019 Determination of Glass Containers' Thermal Shock and Its Strength

13

4020 Determination of Vertical Axis Deviation and Circular Runout of Glass Containers

14

4021 Determination of Linear Thermal Expansion Coefficients of Glass

15

4022 Determination of Average Linear Thermal Expansion Coefficients of Glass

16

4023 Determination of Light-shielding Properties of Colored Glass Containers

17

4024 Determination of Capacity of Glass Containers

18

4201 Determination of Water Resistance of Glass Particles at 121℃

19

4202 Determination of Water Resistance of the Internal Surface of Glass Containers

20

4203 Determination of Diboron Trioxide in Glass

21

9650 Research Guidelines on Sealing Properties of Pharmaceutical Packaging Systems

22

5510 General Chapter on Prefilled Syringes

23

5511 General Chapter on Glass Barrels of Prefilled Syringes

24

5512 General Chapter on Plastic Barrels of Prefilled Syringes

25

5513 General Chapter on Stainless Steel Needles of Prefilled Syringes

26

4040 Test for Luer Taper of Prefilled Syringes

27

4041 Sealing Property Test for Protective Caps of Prefilled Syringes

28

4042 Pull-off Force Test for Protective Caps of Prefilled Syringes

29

4043 Sealing Property Test for Pistons of Prefilled Syringes

30

4044 Unscrewing Torque Determination for Luer Lock Rigid Tip Caps of Prefilled Syringes

31

4045 Torsion Resistance Determination for Adapter Collars of Prefilled Syringes

32

4046 Pull-off Force Determination for Adapter Collars of Pre-filled Syringes

33

4209 General Chapter on the Determination of Ethylene Oxide in Pharmaceutical Packaging Materials

34

4226 Determination of Tungsten Dissolution Amount in Prefilled Syringes

35

4227 Determination of Silicone Oil in Prefilled Syringes

36

5200 General Chapter on Rubber Closures for Pharmaceutical Packaging

37

5201 General Chapter on Rubber Closures for Injections' Packaging

38

5202 General Chapter on Rubber Closures for Oral Dosage Forms' Packaging

39

4204 Determination of Extractables and Leachables of Pharmaceutical Packaging Materials

40

4206 Determination of Insoluble Particles in Pharmaceutical Packaging Materials

41

4214 Determination of Metal Elements and Ions in Pharmaceutical Packaging Materials

42

4219 Determination of Volatile Sulfide in Rubber Closures

43

4220 Determination of Ash Content in Rubber Closures

44

4221 Determination of Water Content in Rubber Closures

45

4222 Determination of Silicone Oil on the Surface of Rubber Closures

46

4223 Determination of Special Residues in Silicone Rubber Closures

If you need English versions of the drafts, please contact BaiPharm for translation service. BaiPharm provides the translation of the Chinese Pharmacopoeia 2020 Edition's standards covering

  • active pharmaceutical ingredients, excipients, and packaging materials;

  • finished dosage forms of chemical drugs and biological products;

  • reagents and reference substances;

  • testing methods;

  • guidelines, etc.

Related Database

Get Access to Chinese Pharmacopoeia Standards of APIs and Excipients

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Grace Wang
ChemLinked Regulatory Analyst
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