Update: China Consults on 46 Pharmaceutical Packaging Material Standards in Pharmacopoeia

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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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.

Reprinted from: ChemLinked

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