Molekula
alpha-D-Lactose monohydrate USP
ISO 9001:2015 & ISO 14001:2015 certified · Supplying laboratories and industry since 2000 · Certificate of Analysis with every batch
Alpha-D-Lactose monohydrate USP is a disaccharide sugar derived from milk, widely used in pharmaceuticals as a tablet excipient, diluent, and binder, as well as in food and beverage production for sweetening and texture enhancement. It meets USP standards for purity and consistency. CAS 5989-81-1, molecular formula C12H22O11·H2O, molecular weight 360.31, and requires ambient storage with no signal word hazards. Molekula supplies alpha-D-Lactose monohydrate USP from research to bulk quantities with full documentation and ISO 9001:2015 traceability.
Overview
Alpha-D-Lactose monohydrate USP is a disaccharide sugar derived from milk, widely used in pharmaceuticals as a tablet excipient, diluent, and binder, as well as in food and beverage production for sweetening and texture enhancement. It meets USP standards for purity and consistency. CAS 5989-81-1, molecular formula C12H22O11·H2O, molecular weight 360.31, and requires ambient storage with no signal word hazards. Molekula supplies alpha-D-Lactose monohydrate USP from research to bulk quantities with full documentation and ISO 9001:2015 traceability.
Pricing & pack sizes
Specifications
| Property | Value |
|---|---|
| Appearance | White to Off-white powder |
| Water | 4.5 - 5.5% |
| Heavy metals | ≤ 5.0μg |
| Loss on Drying | ≤ 0.5% (80°C, 2hours) |
| Solubility | Free soluble in water, practically insoluble in ethanol (96%) |
| Assay | 98.0 - 102.0% |
| Optical Rotation | +54.4 to +55.9° |
| Residue on Ignition | ≤ 0.1% |
| Acidity / Alkalinity | Add 0.3ml of phenolphthalein TS: the solution is colourless and ≤ 0.4 ml of 0.1N sodium hydroxide is required to produce a pink or red colour. |
| Escherichia coli | Absent in 10g |
| Clarity and colour of solution | The solution(1g in 10ml of boiling water) is clear and nearly colorless. Determine the absorbance of this solution at a wavelength of 400 nm. The absorbance divided by the path length, in cm, is ≤ 0.04 |
| Identification B | The principal spot obtained from the Test solution corresponds in appearance and RF value to that obtained from Standard solution A. The test is not valid unless the chromatogram obtained with Standard solution B shows four clearly discernible spots, disregarding any spots at the origin. |
| Mould & Yeast | ≤ 50cfu/g |
| Identification A | FT-IR Conforms to USP reference |
Storage & handling
| Property | Value |
|---|---|
| Storage Temperature | Ambient |
| Acidity | Neutral |
Identification
| Property | Value |
|---|---|
| SKU | 90037408 |
| CAS Number | 5989-81-1 |
| Molecular Formula | C12H22O11·H2O |
| Molecular Weight | 360.31 |
| SMILES | C([C@@H]1[C@@H]([C@@H]([C@H]([C@@H](O1)O[C@@H]2[C@H](O[C@@H]([C@@H]([C@H]2O)O)O)CO)O)O)O)O.O |
| REACH Code | Y113 |
| HTS Code | 2918115100 |
| Tariff Code | 2918110000 |
Safety & GHS
Precautionary statements
- P280 Wear protective gloves/protective clothing/eye protection/face protection
Documents
Safety Data Sheets (SDS)
Available in English, English (US), French, German, Italian, Spanish.
Certificate of Analysis (CoA) by batch
Enter a lot or batch number to retrieve the CoA for that specific batch. We can generate one from spec data if no PDF is on file.
Synonyms
No alternate names recorded for this product.
Frequently asked questions
What is alpha-D-Lactose monohydrate USP commonly used for?
It is primarily used in pharmaceuticals as an excipient in tablets and capsules, and in food and dairy industries as a sweetener, filler, or carrier in powdered products.
What is the chemical formula and molecular weight of alpha-D-Lactose monohydrate?
The formula is **C₁₂H₂₂O₁₁·H₂O**, and the molecular weight is **360.31 g/mol**.
How should alpha-D-Lactose monohydrate USP be stored?
Store in a cool, dry place at ambient temperature, away from moisture and strong odors.
What grade of alpha-D-Lactose monohydrate does Molekula supply?
Molekula supplies **USP-grade** alpha-D-Lactose monohydrate, meeting pharmaceutical standards for purity and consistency.
Can Molekula supply alpha-D-Lactose monohydrate in bulk quantities?
Yes, we offer bulk packaging options for alpha-D-Lactose monohydrate to accommodate large-scale production needs.
What documentation is provided with an order of alpha-D-Lactose monohydrate USP?
Each order includes a **Certificate of Analysis (CoA)**, **Material Safety Data Sheet (MSDS)**, and **USP compliance documentation** for traceability.
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