Products – Anmol Chemicals Private Limited
Lactitol Monohydrate USP
Abstract
It is also known as 4-β-D-galactopyranosyl-D-glucitol, is a sugar alcohol.
Use/Application
It is widely used as an excipients in chemical and pharmaceutical industries.
Identity
Mol. Formula: C12H24O11 .H2O
Mol. Weight: 344.31 g/mol
CAS No.: 81025-04-9
| Test | Specifications……..USP |
| Descriptions | It occurs a white or light brown, odorless crystal. |
| Identification
Test A |
(a) Infrared Absorption |
| Residue of Ignition | Not more than 0.5 % |
| Heavy Metals | Not more than 5 ppm |
| Related Compounds | Not more than 1.5 % |
| Reducing sugars | Not more than 0.2 % |
| Water Determinination | Between 4.5 % – 5.5 % |
| Residual solvents | Meets the requirements |
| Assay | Not less than 98.0 % and not more than 101.0 % on anhydrous basis. |
Shelf life, Storage and Packing
It should be stored in a segregated area in a cool and ventilated place away from combustible materials. Keep in a tightly closed container, sealed until ready for use. It is packed in 25kg or 50kg HDPE bags or drums as required.
Other
We Manufacture Bulk Dugs/API, Excipients, pharmaceuticals (IP/BP/USP/NF/PH. EUR./JP), Speciality Chemicals (Pure/AR/ACS), mineral fortifiers (FCC). our manufacturing facility is GLP, GMP (FDA) approved, ISO 9001, ISO 14001, ISO 22000, FSSC 22000, FSSAI, kosher, halal, COPP and WHO-GMP certified.
Good Manufacturing Practice Certified by World Health Organization (WHO-GMP)
Written Confirmation Certification (WC)
Good Manufacturing Practice (EXCiPACT cGMP)
Good Manufacturing Practice (cGMP)
Good Laboratory Practice (GLP)
