Lactitol EP Impurity B

Name: Lactitol EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-026333

About Lactitol EP Impurity B

Vaqora Chemicals supplies Lactitol EP Impurity B, a pharmacopeial impurity of Lactitol registered under CAS number 53796-37-5. Formula C12H24O11, molecular weight 344.31 g/mol. Its systematic (IUPAC) name is (2R,3R,4R,5R)-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol. Alternative names: Lactitol Monohydrate - Impurity B and Lactitol Impurity B.

It is supplied as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. Handle it with standard laboratory precautions and appropriate personal protective equipment.

Pharmaceutical QC and development laboratories use this impurity standard of Lactitol to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Lactitol

View every impurity, metabolite and intermediate we list for Lactitol.

Lactitol impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Lactitol EP Impurity B
Catalogue No.	VQ-026333
CAS Number	53796-37-5
IUPAC name	(2R,3R,4R,5R)-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol
Molecular formula	C₁₂H₂₄O₁₁
Molecular weight	344.31 g/mol
Exact mass	344.1319
Grade	Reference Standard
HSN code	38229090
InChIKey	VQHSOMBJVWLPSR-QMRWEYQWSA-N
SMILES	C([C@@H]1[C@@H]([C@@H]([C@H]([C@@H](O1)O[C@H]([C@@H](CO)O)[C@@H]([C@@H](CO)O)O)O)O)O)O
PubChem CID	7130189

Physical properties
Physical form	Solid
LogP (XLogP3)	-5.2
H-bond donors / acceptors	9 / 11
TPSA	201 Å²
Synonyms	Lactitol Monohydrate - Impurity B, Lactitol Impurity B, 3-O-beta-D-galactopyranosyl-D-mannitol, GlyTouCan:G68650XP, Lactulitol, beta-D-Galp-(1->3)-Man-ol, beta-D-Galp-(1->3)-Man-OH, D-Mannitol, 3-o-beta-D-galactopyranosyl-

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Lactitol EP Impurity B?

The CAS Registry Number of Lactitol EP Impurity B is 53796-37-5. It is also known as Lactitol Monohydrate - Impurity B, Lactitol Impurity B, 3-O-beta-D-galactopyranosyl-D-mannitol.

What is the molecular formula and molecular weight of Lactitol EP Impurity B?

Lactitol EP Impurity B has the molecular formula C12H24O11 and a molecular weight of 344.31 g/mol. Its IUPAC name is (2R,3R,4R,5R)-4-[(2S,3R,4S,5R,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol.

What is Lactitol EP Impurity B used for?

Lactitol EP Impurity B is supplied as a characterised reference material related to Lactitol. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Lactitol EP Impurity B can I order?

We supply Lactitol EP Impurity B in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Lactitol EP Impurity B?

Yes. Every lot of Lactitol EP Impurity B is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Lactitol EP Impurity B be shipped internationally?

Yes. We export Lactitol EP Impurity B worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.