Macron™ 8830-05 Hydrocortisone, Micronized, USP Grade, 10g Amber Glass Vial
- 10g Amber Glass Vial
- Manufacturer Part No: MK-8830-05
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Details
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₂₁H₃₀O₅) (dried basis) | 97.0 - 102.0 % |
| USP - Organic Impurities | Passes Test |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Loss on Drying | <= 1.0 % |
| USP - Residue on Ignition | <= 0.5 % |
| USP - Specific Rotation [Å]²⁵^D (+) | 150 - 156 Degree |
| EP - Assay (C₂₁H₃₀O₅) | 97.0 - 103.0 % |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Specific Optical Rotation (+) | 162 - 168 Degree |
| EP - Related substances:impurity A | <= 0.2 % |
| EP - Related substances: impurity B | <= 0.2 % |
| EP - Related substances: impurity C | <= 0.5 % |
| EP - Related substances: impurity D | <= 0.5 % |
| EP - Related substances: impurity E | <= 0.5 % |
| EP - Related substances: impurity F | <= 0.3 % |
| EP - Related substances: impurity G | <= 0.4 % |
| EP - Related substances: impurity H | <= 0.15 % |
| EP - Related substances: impurity I | <= 0.5 % |
| EP - Related substances: impurity N | <= 0.15 % |
| EP - Related substances: Total impurities | <= 2.0 % |
| EP - Loss on Drying | <= 1.0 % |
| Only Class 2 Solvents (Methanol) are likely to be present. All are below Option 1 limits. | |
| Product Information (not specifications): | |
| Appearance (white, crystalline powder) | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets E.P. Chemical Specifications | |
| Meets U.S.P Requirements | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (C₂₁H₃₀O₅) (dried basis) | 97.0 - 102.0 % |
| USP - Organic Impurities | Passes Test |
| USP - Identification A | Passes Test |
| USP - Identification B | Passes Test |
| USP - Loss on Drying | <= 1.0 % |
| USP - Residue on Ignition | <= 0.5 % |
| USP - Specific Rotation [Å]²⁵^D (+) | 150 - 156 Degree |
| EP - Assay (C₂₁H₃₀O₅) | 97.0 - 103.0 % |
| EP - Identification A | Passes Test |
| EP - Identification B | Passes Test |
| EP - Specific Optical Rotation (+) | 162 - 168 Degree |
| EP - Related substances:impurity A | <= 0.2 % |
| EP - Related substances: impurity B | <= 0.2 % |
| EP - Related substances: impurity C | <= 0.5 % |
| EP - Related substances: impurity D | <= 0.5 % |
| EP - Related substances: impurity E | <= 0.5 % |
| EP - Related substances: impurity F | <= 0.3 % |
| EP - Related substances: impurity G | <= 0.4 % |
| EP - Related substances: impurity H | <= 0.15 % |
| EP - Related substances: impurity I | <= 0.5 % |
| EP - Related substances: impurity N | <= 0.15 % |
| EP - Related substances: Total impurities | <= 2.0 % |
| EP - Loss on Drying | <= 1.0 % |
| Only Class 2 Solvents (Methanol) are likely to be present. All are below Option 1 limits. | |
| Product Information (not specifications): | |
| Appearance (white, crystalline powder) | |