MEDIOCON INC – Lactose is a naturally occurring disaccharide composed of glucose and galactose and is widely used as a pharmaceutical excipient. It is commonly used as a diluent, filler and carrier in tablets, capsules, powders and other pharmaceutical dosage forms. Lactose is available in different pharmaceutical grades and physical forms, including anhydrous lactose and lactose monohydrate.
Lactose is an important pharmaceutical excipient because of its established use as a tablet and capsule diluent/filler. Its physical properties can vary according to whether it is supplied as anhydrous lactose, lactose monohydrate, spray-dried lactose or another processed grade.
The International Pharmacopoeia recognizes both anhydrous lactose and lactose monohydrate and identifies lactose as a tablet and capsule diluent.
Product Name: Lactose
CAS Number: 63-42-3
Molecular Formula: C₁₂H₂₂O₁₁
Molecular Weight: 342.30 g/mol (anhydrous)
Chemical Class: Disaccharide / Pharmaceutical excipient
Functional Class: Diluent / Filler / Carrier
Synonyms: Lactobiose, Milk Sugar, D-Lactose, Saccharum Lactis
PubChem CID: 6134
NIST confirms the CAS number 63-42-3, molecular formula C₁₂H₂₂O₁₁ and molecular weight 342.2965 g/mol for lactose.
Lactose is commercially available in several forms, including:
The molecular weight of lactose monohydrate is approximately 360.32 g/mol, compared with 342.30 g/mol for anhydrous lactose. (who.int)
Lactose does not have a pharmacological mechanism of action when used as an excipient. Its primary function is technological.
In pharmaceutical formulations, lactose can provide bulk, improve powder handling and support tablet/capsule manufacturing. Depending on the specific grade and processing method, lactose can also be used in direct compression and as a carrier in dry-powder formulations.
MEDIOCON INC focuses on supplying pharmaceutical and specialty ingredients with emphasis on quality, consistency, technical documentation and reliable supply.
Lactose quality evaluation may include identification, assay, water content, acidity/alkalinity, residue on ignition, optical rotation, microbial quality and other parameters according to the applicable pharmacopoeial monograph and product specification.
The exact analytical acceptance criteria should be confirmed against the applicable grade and batch-specific Certificate of Analysis.
Lactose is widely used in pharmaceutical formulations as:
The International Pharmacopoeia specifically categorizes lactose as a tablet and capsule diluent.
Lactose is generally described as a white or almost white crystalline powder. USP/FCC information describes lactose as white to creamy white crystalline powder.
Appearance: White to almost white crystalline powder
For anhydrous lactose, the European Pharmacopoeia description is white or almost white, crystalline powder.
Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and other documentation should be confirmed with MEDIOCON INC according to the intended application and customer requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to almost white crystalline powder |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Lactose API Manufacturer and Supplier in India (CAS 63-42-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Lactose API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.
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