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.
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
Reference Links
- Webinar: Understanding Chinese Pharmacopoeia (ChP) 2020
- China Consults on 11 Packaging Material Standards in Pharmacopoeia
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