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Sultamicillin Impurities

Sultamicillin is an oral mutual prodrug composed of:
∙ Ampicillin – a broad-spectrum penicillin-type β-lactam antibiotic
∙ Sulbactam – a β-lactamase inhibitor
Sultamicillin is designed to improve oral absorption and bioavailability of both components. Once ingested, it is hydrolyzed in the body to release ampicillin and sulbactam, which act synergistically to treat β-lactamase-producing bacterial infections.
It is commonly used to treat:
∙ Respiratory tract infections
∙ Urinary tract infections (UTIs)
∙ Skin and soft tissue infections
∙ Gynecological infections

Structure

Product Name

CAS No.

Cat No.

Action

Lisinopril EP Impurity B

Lisinopril EP Impurity B

Parent: Lisinopril / Tizanidine / Anastrozole / Sultamicillin

CAS No.: 6192-52-5

Cat No.: VL600003

Sultamicillin EP Impurity A

Parent: Sultamicillin

CAS No.: N/A

Cat No.: VE0017032

Sultamicillin EP Impurity D

Parent: Sultamicillin

CAS No.: N/A

Cat No.: VE0017033

Sultamicillin EP Impurity E

Parent: Sultamicillin

CAS No.: N/A

Cat No.: VE0017035

Sultamicillin EP Impurity F

Parent: Sultamicillin / Ampicillin

CAS No.: N/A

Cat No.: VE0017036

Sultamicillin EP Impurity G

Parent: Sultamicillin

CAS No.: N/A

Cat No.: VE0017038

Sultamicillin Tosylate Working Standard (Secondary Reference Standard)

Parent: Sultamicillin/ Sultamicillin Tosylate

CAS No.: 83105-70-8

Cat No.: VE0027574

Sultamicillin Working Standard (Secondary Reference Standard)

Parent: Sultamicillin

CAS No.: 76497-13-7

Cat No.: VE0027572

Sultamicillin Related Compound

Impurities in sultamicillin can arise from the synthetic process, storage conditions, or degradation, and must be controlled in line with ICH Q3A/B and pharmacopeial standards.

Types of Impurities in Sultamicillin

Process-Related Impurities

Unreacted starting materials such as ampicillin or sulbactam precursors
By-products from esterification or condensation reactions
Residual solvents like methanol, ethyl acetate, or acetone

Degradation Impurities

Hydrolyzed forms of the ampicillin or sulbactam moiety under humid or acidic conditions
Oxidative degradation products
Ring-opened β-lactam degradation due to temperature or pH instability

Elemental Impurities

Trace metals (e.g., tin, copper, iron) from manufacturing equipment or catalysts

Analytical Techniques for Impurity Detection

High-Performance Liquid Chromatography (HPLC)
Mass Spectrometry (MS)
Nuclear Magnetic Resonance (NMR)
Fourier-Transform Infrared Spectroscopy (FT-IR)
ICP-MS for elemental impurity analysis

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