Spiramycin Impurity Standards

Spiramycin impurity reference standards are used by pharmaceutical quality-control laboratories, contract research organisations, and generic drug manufacturers to identify, quantify, and control Spiramycin-related impurities during analytical method development, method validation, and regulatory filing. As a macrolide antibiotic, Spiramycin 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 Spiramycin 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

SPIRAMYCIN

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
68880-55-7

Molecular Formula: C43H74N2O14 : C6H10O4

Molecular Weight: 843.1 : 146.1

CAT No:
ALL-S09297

Keywords: SMILES string - O=CC[C@@H]1[C@H](O[C@H]2...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY A

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
70253-62-2

Molecular Formula: C36H62N2O11

Molecular Weight: 698.9

CAT No:
ALL-S09299

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

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY B

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
249930-66-3

Molecular Formula: C43H76N2O14

Molecular Weight: 845.1

CAT No:
ALL-S09298

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

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY C

Chemical Name: (4R,5S,6S,7S,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
177584-13-3

Molecular Formula: C44H74N2O14

Molecular Weight: 855.1

CAT No:
ALL-S09300

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

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY D

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
87708-39-2

Molecular Formula: C42H71NO16

Molecular Weight: 846.0

CAT No:
ALL-S09301

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

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY F

Chemical Name: Spiramycin Dimer (as per EP)

CAS No:
N.A.

Molecular Formula: C84H140N4O26

Molecular Weight: 1622.0

CAT No:
ALL-S09303

Keywords: SMILES string - O=C1O[C@]([H])(C)C/C=C/C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY G

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
N.A.

Molecular Formula: C38H64N2O12

Molecular Weight: 740.9

CAT No:
ALL-S09304

Keywords: SMILES string - O=C1O[C@]([H])(C)C/C=C/C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN EP IMPURITY H

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-[[3,6...

CAS No:
4617-99-6

Molecular Formula: C39H66N2O12

Molecular Weight: 755.0

CAT No:
ALL-S09305

Keywords: SMILES string - O=C1O[C@]([H])(C)C/C=C/C...

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN I

Chemical Name: 2-((4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-((...

CAS No:
24916-50-5

Molecular Formula: C43H74N2O14

Molecular Weight: 843.1

CAT No:
ALL-S09306

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

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

SPIRAMYCIN III

Chemical Name: (4R,5S,6S,7R,9R,10R,11E,13E,16R)-6-(((2S...

CAS No:
24916-52-7

Molecular Formula: C46H78N2O15

Molecular Weight: 899.1

CAT No:
ALL-S09307

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

Inventory Status:DELIVERY 3-4 WEEKS

COA MSDS

Key Spiramycin Impurity Variants Available

Spiramycin EP Impurity B (Leucomycin V, 18 — deoxo-9-O-substituted derivative)-a leucomycin-type congener impurity
Spiramycin EP Impurity D (Spiramycin V) — a deacylated congener impurity formed by loss of the acyl substituent
Spiramycin EP Impurity H (Neospiramycin III) — a demethylated congener monitored as a related substance
Neospiramycin I — the deacylated parent congener of Spiramycin I, commonly controlled alongside the named EP impurities
Spiramycin II / Spiramycin III — the co-produced fermentation congeners present alongside Spiramycin I in the commercial mixture

Allmpus Capability for the Spiramycin/Macrolide Family

Allmpus Laboratories manufactures and isolates Spiramycin impurities using preparative isolation techniques suited to the multi-congener, fermentation-derived nature of 16-membered macrolides. Each impurity is supplied with a Certificate of Analysis supported by ¹H NMR, ¹³C NMR, mass spectrometry, HPLC, IR, and TGA data, allowing customers to confirm structural identity and purity before use in stability-indicating method development, method validation, or routine QC testing of Spiramycin drug substance and adipate salt formulations. Allmpus's macrolide capability extends across 14- and 16-membered ring systems, including Spiramycin, Erythromycin, and Azithromycin impurity families, and is manufactured at its Dombivali, Maharashtra facility for supply to pharmaceutical manufacturers and contract testing laboratories.

Frequently Asked Questions

Are Allmpus Spiramycin impurity standards referenced to EP and USP designations?

Yes. Where a pharmacopeial designation exists, the corresponding EP impurity letter is provided along with the chemical name and any commonly used congener synonym, to support direct use in monograph-based testing.

What analytical data is provided with each impurity standard?

Each standard is issued with a Certificate of Analysis that includes NMR (¹H and ¹³C), mass spectrometry, HPLC purity, IR, and TGA data to support identity and purity confirmation.

Are these standards suitable for human use?

No. Spiramycin impurity standards are supplied strictly for analytical, research, and reference purposes, including method development and quality control testing, and are not intended for human or veterinary administration.