Clindamycin Hydrochloride Impurity Standards

Clindamycin HCl impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Clindamycin HCl-related impurities during analytical method development, method validation, and regulatory filing. As a lincosamide antibiotic, Clindamycin HCl requires precise characterisation of its process impurities, degradation products, and related substances to meet European Pharmacopoeia (EP), United States Pharmacopeia (USP), and British Pharmacopoeia (BP) monograph requirements. Allmpus Laboratories manufactures and supplies a comprehensive library of Clindamycin HCl impurity standards, each provided with a Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS). All products are held in-stock for rapid dispatch and are suitable for use in ANDA and DMF regulatory submissions.

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

CLINDAMYCIN DEHYDRO IMPURITY

Chemical Name: Methyl 7-Chloro-6,7,8-trideoxy-6-[[[(2S)...

CAS No:
909032-77-5 (base)

Molecular Formula: C18H32Cl2N2O5S

Molecular Weight: 459.43

CAT No:
ALL-CIN-1158

Keywords: SMILES string - C[C@H](Cl)[C@H]([C@@]([C...

Inventory Status:IN STOCK/04-261

COA MSDS

CLINDAMYCIN EP IMPURITY A

Chemical Name: (2S, 4R)-N-[(1R, 2R)-2-Hydroxy-1-[(2R, 3...

CAS No:
859-18-7 (HCl salt) | 154-21-2

Molecular Formula: C18H34N2O6S (FREE BASE)

Molecular Weight: 406.54 (FREE BASE)

CAT No:
ALL-C03694

Keywords: SMILES string - C[C@@H](O)[C@@]([C@@]([C...

Inventory Status:IN STOCK/05-284

COA MSDS

CLINDAMYCIN EP IMPURITY B

Chemical Name: (2R)-N-(2-chloro-1-((3R,4R,6R)-3,4,5-tri...

CAS No:
18323-43-8

Molecular Formula: C17H31ClN2O5S

Molecular Weight: 410.96

CAT No:
ALL-C02755

Keywords: SMILES string -C[C@@](Cl)([H])[C@](NC([C...

Inventory Status:IN STOCK/04-257

COA MSDS

CLINDAMYCIN HCl EP IMPURITY C | 7-EPI CLINDAMYCIN HYDROCHLORIDE

Chemical Name: (2S-trans)-Methyl 7-Chloro-6,7,8-trideox...

CAS No:
16684-06-3 (Free base) | 17431-55-9

Molecular Formula: C18H34Cl2N2O5S

Molecular Weight: 461.44

CAT No:
ALL-C02989

Keywords: SMILES string - CCCC1CC(N(C1)C)C(=O)NC(C...

Inventory Status:IN STOCK/04-258

COA MSDS

CLINDAMYCIN HYDROCHLORIDE

Chemical Name: Methyl 7-chloro-6,7,8-trideoxy-6-[[[(2S,...

CAS No:
58207-19-5 (Monohydrate) | 21462-39-5 (HCl) | 18323-44-9 (Base)

Molecular Formula: C18H34Cl2N2O5S

Molecular Weight: 461.44

CAT No:
ALL-C03695

Keywords: SMILES string - C[C@H](Cl)[C@@]([C@@]([C...

Inventory Status:IN STOCK/04-262

COA MSDS

CLINDAMYCIN IMPURITY (SULFONE)

Chemical Name: (2S,4R)-N-((1S,2S)-2-Chloro-1-((2R,3R,4S...

CAS No:
887402-22-4

Molecular Formula: C18H33ClN2O7S

Molecular Weight: 457.0

CAT No:
ALL-C03399

Keywords: SMILES string -C[C@H](Cl)[C@@]([C@@]([C@...

Inventory Status:IN STOCK/04-265

COA MSDS

CLINDAMYCIN N-OXIDE

Chemical Name: (2S)-2-((2-Chloro-1-((2R,3R,4S,5R,6R)-3,...

CAS No:
N.A

Molecular Formula: C18H33ClN2O6S

Molecular Weight: 440.98

CAT No:
ALL-C03400

Keywords: SMILES string - C[C@H](Cl)[C@@]([C@@]([C...

Inventory Status:IN STOCK/04-277

COA MSDS

CLINDAMYCIN SULFOXIDE ISOMER A

Chemical Name: (2S,4R)-N-((1S,2S)-2-chloro-1- ((2R,3R,4...

CAS No:
N.A

Molecular Formula: C18H33ClN2O6S

Molecular Weight: 440.98

CAT No:
ALL-C04297

Keywords: SMILES string - C[C@H](Cl)[C@@]([C@@]([C...

Inventory Status:IN STOCK

COA MSDS

CLINDAMYCIN SULFOXIDE ISOMER B

Chemical Name: (2S,4R)-N-((1S,2S)-2-chloro-1- ((2R,3R,4...

CAS No:
22431-46-5

Molecular Formula: C18H33ClN2O6S

Molecular Weight: 440.98

CAT No:
ALL-C03050

Keywords: SMILES string - C[C@H](Cl)[C@@]([C@@]([C...

Inventory Status:IN STOCK/04-259

COA MSDS

DEHYDRO CLINDAMYCIN

Chemical Name: methyl 7-chloro-6,7,8-trideoxy-6-[[[(2S)...

CAS No:
1440605-51-5

Molecular Formula: C18H31ClN2O5S

Molecular Weight: 423.0

CAT No:
ALL-C08636

Keywords: SMILES string - C[C@@](Cl)([H])[C@](NC([...

Inventory Status:IN STOCK

COA MSDS

ISOPROPYLIDENE CLINDAMYCIN

Chemical Name: (2S-trans)-Methyl 7-Chloro-6,7,8-trideox...

CAS No:
147650-54-2

Molecular Formula: C21H37ClN2O5S

Molecular Weight: 465.05

CAT No:
ALL-C03112

Keywords: SMILES string - C[C@H](Cl)[C@@]([C@]1([H...

Inventory Status:IN STOCK/04-269

COA MSDS

Key Clindamycin Hydrochloride Impurity Variants

Clindamycin Hydrochloride EP Impurity B (CAS 18323 — 43-8)-a des-chloro/ethyl-substituted analogue listed as a specified impurity in the Ph. Eur. monograph
Clindamycin Impurity C (7 — Epiclindamycin, CAS 16684-06-3)-a stereochemical epimer at the 7-position, relevant to confirming method specificity
Clindamycin Impurity D (7 — Epilincomycin hydrochloride, CAS 26389-84-4)-an epimeric lincomycin-derived impurity used in related-substance profiling
Clindamycin Hydrochloride EP Impurity E (CAS 1440605 — 51-5)-a specified process-related impurity recognized in the Ph. Eur. monograph
Clindamycin Hydrochloride EP Impurity F (CAS 1440605 — 46-8)-an additional specified impurity used to complete impurity-profile coverage under the Ph. Eur. monograph
Sulfoxide isomers and N — oxide degradation products are also available where relevant to oxidative stability studies of the drug substance.

Allmpus's Capability for This Drug Family

Allmpus Laboratories manufactures and supplies clindamycin hydrochloride and its related impurities, including EP-designated variants such as Clindamycin Hydrochloride EP Impurity B, alongside a broader portfolio covering clindamycin phosphate impurities, sulfoxide isomers, and N-oxide degradation products. Because several clindamycin impurities differ from the parent molecule only by a single stereocenter or oxidation state, isolating and confirming these species requires preparative purification techniques capable of resolving closely related lincosamide structures. Each compound is released with a Certificate of Analysis comprising ¹H NMR, ¹³C NMR, mass spectrometry, HPLC purity, IR, and TGA data, supporting customers' method validation, impurity qualification, and regulatory documentation requirements. Allmpus's R&D and manufacturing operations, based in Maharashtra, India, support API manufacturers, generic drug developers, and contract research organizations sourcing clindamycin-related reference standards for QC testing and DMF/ANDA support work.

Frequently Asked Questions

Why is 7-Epiclindamycin (Impurity C) significant in clindamycin quality control?

7-Epiclindamycin is a stereochemical epimer that can co-elute closely with the main clindamycin peak in HPLC analysis, so it is used as a reference standard to confirm that analytical methods achieve adequate resolution between the two.

What is the relationship between clindamycin hydrochloride impurities and clindamycin phosphate impurities?

Because clindamycin phosphate is derived from clindamycin, several related substances (such as 7-Epiclindamycin and its phosphate ester) appear across both drug substance forms, so impurity profiling for one form often requires reference standards relevant to the other.

Why does clindamycin hydrochloride require particular attention to stability-related impurities?

Clindamycin hydrochloride has documented stability limitations, meaning multiple degradation-related impurities can form during storage or formulation, making stability-indicating method validation with well-characterized impurity standards especially important for this drug substance.