Certificate of Analysis
Capsules from Hypromellose (Hydroxypropyl Methyl Cellulose)
No. C01-15033
Name | HPMC Capsule | Batch No. | |
Size | 0# | Production Date | 06.23.2020 |
Quantity(Granule) | 100,000 | Expiration Date | 06.22.2025 |
Packing | 100,000/carton | Report Date | 06.30.2020 |
Body Color | Transparent | Cap Color | Transparent |
Body Component | Hypromellose qsp 100% | Cap Component | Hypromellose qsp 100% |
Ingredient/Reference | EEC nr. | Function | Pharmacopeia References |
Hypromellose | E464 | Structure | EP/USP-NF/FCC |
Technical Data | ||||
Characteristics | Test method | Units | Specifications | Results |
Hypromellose identification | TS.QC.C01 | Positive | Pass | |
Disintegration time | TS.QC.C01 | min | ≤15 | Conform |
Lubricant content | TS.QC.C01 | % | ≤0.5 | 0.3 |
Loss on drying | TS.QC.C01 | % | ≤8.5 | 4.9 |
Residue content | TS.QC.C01 | % | ≤3.0 | 4.0 |
Heavy metal | TS.QC.C01 | % | ≤0.0010 | ＜0.0010 |
Arsenic | TS.QC.C01 | % | ≤0.0002 | ＜0.0002 |
Total bacteria count | TS.QC.C01 | cfu/g | ≤1000 | ＜10 |
Total yeast and mold count | TS.QC.C01 | cfu/g | ≤100 | ＜10 |
Single wall thickness caps/body | TS.QC.C01 | mm | 0.095~0.125/0.09~0.120 | Confirmed |
Average weight | TS.QC.C01 | mg | 92~102 | Confirmed |
Length cap/body | TS.QC.C01 | mm | 10.80~11.20/18.3~18.7 | Confirmed |
Outside diameter cap/body | TS.QC.C01 | mm | 7.61~7.71/7.30~7.40 | Confirmed |
Joint length | TS.QC.C01 | mm | 22.95~24.55 | Confirmed |
Salmonella.SP | TS.QC.C01 | Not detected | Not detected | |
B-Pseudomonas aeruinosa | TS.QC.C01 | Not detected | Not detected | |
C-Candida alicans | TS.QC.C01 | Not detected | Not detected | |
Escherichia coli | TS.QC.C01 | Not detected | Not detected | |
Staphylococcus aureus | TS.QC.C01 | Not detected | Not detected | |
Conclusion |
Product complies with Healsee HPMC standard. |
Note: No preservatives, no ethylene oxide sterilization, no radiation treatment |
