For pharmaceutical buyers and quality control professionals, understanding the precise specifications of Active Pharmaceutical Ingredients (APIs) is non-negotiable. Carbocisteine (CAS 638-23-3), a cornerstone in mucolytic therapy, demands rigorous adherence to quality standards. This guide outlines the key specifications that buyers should focus on when sourcing Carbocisteine.

Defining Quality for Carbocisteine

The efficacy and safety of any pharmaceutical product are directly linked to the quality of its API. For Carbocisteine, these specifications ensure it performs as intended in treating respiratory conditions characterized by excessive or thickened mucus.

Essential Specifications for Carbocisteine (CAS 638-23-3)

When you look to buy Carbocisteine, always verify the following critical parameters:

1. Assay: This refers to the purity of the Carbocisteine. A typical specification is 99% minimum. A higher assay indicates less impurities and a more potent active ingredient, which is crucial for consistent dosing and therapeutic outcomes.

2. Appearance: Carbocisteine is generally described as a white crystalline powder or small flakes. Any deviation from this appearance can indicate potential contamination or degradation.

3. Specific Rotation: This optical property is a key indicator of stereochemical purity. For Carbocisteine, the specific rotation typically falls within a defined range (e.g., -32.5° to -35.5°).

4. Loss on Drying and Residue on Ignition: These tests quantify volatile substances and inorganic impurities, respectively. Low values are indicative of a well-purified product.

5. Heavy Metals and Sulphated Ash: Limits for heavy metals (e.g., ≤10 ppm) and sulphated ash (e.g., ≤0.30%) are essential to ensure the safety of the API, particularly for oral administration.

6. Related Substances/Ninhydrin-positive substances: These specifications control the presence of process-related impurities and degradation products. Strict limits ensure the chemical integrity of the API.

Choosing a Reliable Carbocisteine Manufacturer

As a dedicated Carbocisteine manufacturer and supplier, NINGBO INNO PHARMCHEM CO.,LTD. provides Carbocisteine (CAS 638-23-3) that meets all these critical specifications. We understand the importance of quality in pharmaceutical manufacturing. Contact us today to receive our Certificate of Analysis and to discuss your requirements for this essential pharmaceutical intermediate. We are your trusted source for high-purity APIs.