Certificate of Analysis and technical specification for Gelatin Capsule Grade — CAS 9000-70-8. Applies to all consignments of this product and grade.
| Product Name | Gelatin Capsule Grade |
|---|---|
| C.A.S. Number | 9000-70-8 |
| Product Category | Pharmaceutical Excipients |
| Product Group | Capsule Shell Materials |
| Grade / Standard | IP/BP/USP/EP |
| Physical Form | Light yellow granules/powder |
| Country of Origin | India |
| Packing | Standard export packing — bags, drums, carboys, IBC or ISO tank as applicable |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
| S. No. | Test Parameter | Specification | Typical Result | Method |
|---|---|---|---|---|
| 1 | Description | Light yellow granules/powder | Complies | Visual |
| 2 | Identification (A) — Infrared absorption | Concordant with reference spectrum | Complies | IR Spectrophotometry |
| 3 | Identification (B) — Chemical / chromatographic | Positive for the substance | Complies | As per monograph |
| 4 | Solubility | As per specification | Complies | Visual / Monograph |
| 5 | Assay (on dried basis) | 98.0 – 102.0 % w/w | 99.04 | HPLC / Titrimetry (Monograph) |
| 6 | pH (aqueous dispersion) | As per monograph | 5.2 | Potentiometry |
| 7 | Bulk Density | As per specification | 0.46 g/mL | USP <616> |
| 8 | Tapped Density | As per specification | 0.44 g/mL | USP <616> |
| 9 | Particle Size (d50) | As per specification | 56 µm | Laser diffraction |
| 10 | Loss on Drying | Not more than 1.0 % w/w | 0.13 | Gravimetry (Monograph) |
| 11 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.028 | Gravimetry (Monograph) |
| 12 | Heavy Metals | Not more than 20 ppm | Less than 10 ppm | ICP-OES / Limit test |
| 13 | Related Substances — any individual impurity | Not more than 0.10 % | 0.030 | HPLC |
| 14 | Related Substances — total impurities | Not more than 0.50 % | 0.068 | HPLC |
| 15 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
| 16 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 97 cfu/g | IP / USP <61> |
| 17 | Total Yeast & Mould Count | Not more than 100 cfu/g | 6 cfu/g | IP / USP <61> |
| 18 | Escherichia coli | Absent in 1 g | Absent | IP / USP <62> |
| 19 | Salmonella species | Absent in 10 g | Absent | IP / USP <62> |
This document sets out the standard specification for Gelatin Capsule Grade and applies to all consignments of this grade. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we will confirm compliance before order.
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