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
Loratadine Key Intermediate
Formulated product · ≥97% Technical
1. Product identity
| Product name | Loratadine Key Intermediate |
|---|---|
| C.A.S. number | Applicable to blend — on request |
| Grade / standard | ≥97% Technical |
| Description | Off-white to pale yellow powder |
| Product group | Antihistamine Intermediates |
| Category | Pharmaceutical Intermediates |
| 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 | Off-white to pale yellow powder | Complies | Visual |
| 2 | Solubility | As per specification | Complies | Visual / Monograph |
| 3 | Assay | Not less than 97.0 % w/w | 97.44 | Titrimetry / Instrumental |
| 4 | Clarity & Colour of Solution | Clear; not more intensely coloured than reference | Complies | Visual (Monograph) |
| 5 | pH (1 % w/v aqueous solution) | As per monograph | 6.7 | Potentiometry |
| 6 | Water Content (Karl Fischer) | Not more than 0.5 % w/w | 0.15 | Karl Fischer titration |
| 7 | Melting Range / Point | As per monograph | Complies | Capillary method |
| 8 | Particle Size (d90) | As per specification | 141 µm | Laser diffraction |
3. Declaration
This document sets out the standard specification for Loratadine Key Intermediate 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.
SCAPEXQUALITY ASSURED