Impurity Reference Standard - Products

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Cleanchem is a trusted provider of premium pharmaceutical reference materials, specializing in Lactitol and its associated compounds. Our catalog includes pharmacopeial and non-pharmacopeial Lactitol impurities, metabolites, nitrosamine derivatives (N-NO compounds), and stable isotope-labeled products. These reference standards play a critical role in pharmaceutical R&D, supporting activities such as product formulation, ANDA and DMF submissions, quality assurance, analytical method development, and stability assessments.
All Lactitol-related substances undergo comprehensive characterization and are delivered with complete Certificates of Analysis and supporting analytical documentation to ensure regulatory adherence. Upon request, we can offer EP/USP traceable standards. Our products are routinely re-evaluated to maintain consistent quality and performance.

Lactitol EP Impurity A

CAT No: CL-LCT-02 CAS No: 63-42-3 Mol Wt: 342.3 Mol F: C12H22O11 Inv Status: Custom Synthesis

Chemical Name: 4-O-?-D-galactopyranosyl-D-glucopyranose

Lactitol EP Impurity B

CAT No: CL-LCT-03 CAS No: NA Mol Wt: 344.3 Mol F: C12H24O11 Inv Status: Custom Synthesis

Chemical Name: 3-O-?-D-galactopyranosyl-D-glucitol

Lactitol EP Impurity C

CAT No: CL-LCT-04 CAS No: 69-65-8 Mol Wt: 182.2 Mol F: C6H14O6 Inv Status: Custom Synthesis

Chemical Name: D-Mannitol

Lactitol EP Impurity D

CAT No: CL-LCT-05 CAS No: 608-66-2 Mol Wt: 182.2 Mol F: C6H14O6 Inv Status: Custom Synthesis

Chemical Name: Galactitol

Lactitol EP Impurity E

CAT No: CL-LCT-06 CAS No: 50-70-4 Mol Wt: 182.2 Mol F: C6H14O6 Inv Status: Custom Synthesis

Chemical Name: D-Glucitol

Lactitol Monohydrate

CAT No: CL-LCT-07 CAS No: 81025-04-9 Mol Wt: 344.3 : 18.0 Mol F: C12H24O11 : H2O Inv Status: Custom Synthesis

Chemical Name: 4-O-?-d-Galactopyranosyl-d-glucitol monohydrate (as per EP & USP)

Lactitol EP Impurity A (Hydrate)

CAT No: CL-LCT-08 CAS No: 64044-51-5 Mol Wt: 342.3 : 18.0 Mol F: C12H22O11 : H2O Inv Status: Custom Synthesis

Chemical Name: (2R,3R,4R,5R)-2,3,5,6-Tetrahydroxy-4-(((2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)tetrahydro-2H-pyran-2-yl)oxy)hexanal hydrate

Type:Impurity Reference Standard

Total Products: 7

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