Scapex Exports Pvt. Ltd.
830, 8th Floor, Sun Gravitas, Times of India Road,
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Certificate of AnalysisStandard product specification
HPMC K100M
CAS 9004-65-3 · IP/BP/USP/EP
1. Product identity
| Product name | HPMC K100M |
|---|---|
| C.A.S. number | 9004-65-3 |
| Grade / standard | IP/BP/USP/EP |
| Description | White to off-white powder |
| Product group | Sustained Release Polymers |
| Category | Pharmaceutical Excipients |
| Country of origin | India |
| Packing | Bags, drums, carboys, IBC or ISO tank as applicable — customer-specified packing available |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
2. Analytical specification
| S. No. | Test parameter | Specification | Typical result | Method |
|---|---|---|---|---|
| 1 | Description | White to off-white 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 | 99.40 | HPLC / Titrimetry (Monograph) |
| 6 | pH (aqueous dispersion) | As per monograph | 5.2 | Potentiometry |
| 7 | Bulk Density | As per specification | 0.37 g/mL | USP <616> |
| 8 | Tapped Density | As per specification | 0.60 g/mL | USP <616> |
| 9 | Particle Size (d50) | As per specification | 60 µm | Laser diffraction |
| 10 | Loss on Drying | Not more than 1.0 % w/w | 0.45 | Gravimetry (Monograph) |
| 11 | Sulphated Ash / Residue on Ignition | Not more than 0.1 % w/w | 0.012 | 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 % | 0.049 | HPLC |
| 14 | Related Substances — total impurities | Not more than 0.50 % | 0.065 | HPLC |
| 15 | Residual Solvents | Complies with ICH Q3C limits | Complies | Headspace GC |
| 16 | Total Aerobic Microbial Count | Not more than 1000 cfu/g | 74 cfu/g | IP / USP <61> |
| 17 | Total Yeast & Mould Count | Not more than 100 cfu/g | 8 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> |
3. Declaration
This document sets out the standard specification for HPMC K100M and applies to all consignments of this product and grade supplied by Scapex Exports Pvt. Ltd. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with, and travels with, each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we confirm compliance in writing before the order is accepted.
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