CAS 64044-51-5
Lactose Monohydrate
Lactose Monohydrate is a pharmaceutical filler for tablets and capsules, supplied in direct-compression grades to Ph. Eur./USP-NF.
Lactose is a milk sugar refined to pharmaceutical purity. It is cheap, inert to most APIs, pleasant tasting and dissolves well, so it is one of the most common fillers in tablets and capsules. Milled grades are used in wet granulation; spray-dried and granulated grades flow and compress well enough for direct compression.
Because it is a reducing sugar, lactose can react with APIs that contain primary amines (the Maillard reaction), causing discolouration. Formulators screen for that interaction early. Specialist inhalation grades are used as carriers in dry powder inhalers.
- CAS number
- 64044-51-5
- Grades / forms
- Direct compression
- Industries
- Pharma
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Request a quotation- Certificate of Analysis with every batch
- MSDS in destination format
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- Private label packing available
Typical applications
- Direct compression tablets (spray-dried grades)
- Wet granulation filler (milled grades)
- Capsule filling
- Sachets and dry syrups
- Carrier in dry powder inhalers (inhalation grades)
Packing options
- 25 kg multi-wall paper bags with PE liner
Storage & handling
Store in closed containers in a cool, dry place away from strong odours.
Documentation
Certificate of Analysis, MSDS, Certificate of Origin, dangerous goods declaration where applicable, and third-party pre-shipment inspection on request.
Typical specification
- Standard
- Ph. Eur. / USP-NF
- Water (Karl Fischer)
- 4.5–5.5%
- Loss on drying
- ≤ 0.5%
- Microbial limits
- Per pharmacopoeia
Typical values for reference. The exact specification is agreed before the order and confirmed on the Certificate of Analysis for each batch.
Lactose Monohydrate — frequently asked
The Maillard reaction is a browning reaction between lactose, a reducing sugar, and APIs containing primary amine groups. It can discolour tablets and degrade the API, so compatibility is checked early in development.
Spray-dried and granulated lactose monohydrate grades are used for direct compression because they flow well and form strong tablets. Milled grades are better suited to wet granulation.
The amount of lactose in a typical tablet is small and is generally tolerated by most lactose-intolerant patients, but product labelling should declare it as required by local regulations.
Yes. Chemtrade manufactures and exports Lactose Monohydrate (CAS 64044-51-5) from Surat, Gujarat, India to more than 55 countries, for customers in Pharma. Send your grade, quantity and destination port for a quotation within one business day.
Every shipment of Lactose Monohydrate from Chemtrade includes a batch-specific Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). Certificate of Origin, third-party pre-shipment inspection and destination-specific regulatory documentation are arranged on request.
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