API(active pharmaceutical ingredient)
Menthol Crystal
- Menthol Crystal
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Certificate of Analysis
Menthol Crystal
Manufacture Date | 29 NOV. , 2016 | Batch/Lot No.: | 1611279 | |
Expiry Date | 28 NOV. , 2019 | Package (N.W) | 25kgs/drum | |
Quality Criterion | B P2005 / USP32 / GB3862-2006 | Quantity | 10000kgs | |
Testing Report | ||||
Testing Items | Quality Criterion | Testing Result | ||
Color And Appearance | Colorless, Transparent Hexagonal Or Needlelike Crystals | Conform | ||
Odor | Have the characteristic odor of Chinese natural menthol | Conform | ||
Identification | Shall comply with the USP requirement | Conform | ||
Melting Point(℃) | 41.5℃~44℃ | 41.55℃-42.6℃ | ||
Solubility(25℃) | Melting 1 gram test sample into 5ml 90% alcohol | Conform | ||
Non - Volatile Content | ≤ 0.05% | 0.0180% | ||
Organic volatile impurities | Shall comply with the USP requirement | Conform | ||
Specific Rotation(25℃) | - 50°~ - 49° | -49.50° | ||
Arsenic Content (mg/kg) | ≤ 3 | <3 | ||
Heavy Metal, as Pb(mg/kg) | ≤ 10 | <10 | ||
Purity | ≥ 99.5% | 99.51% | ||
Microbiological Contamination/g A) Total aerobic microbial count B) Total conbined moulds & yeasts C) Other specific micro organisms(E.Coli, Salmonella sp) |
≤1000 cfu ≤100 cfu Absent in 1g | |||
Testing Results | As Standard of B P2005 / USP32 / GB3862-2006 | Conform | ||
Storage Condition | Dry And Cool Place Below 25℃, Away From Heating Or Ignition; Avoid Direct Shining; Must Re-Inspect Each Half Year. |
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