Understanding the material
The hydrochloride and free-base names are not interchangeable purchasing descriptions. Water associated with the salt also affects its formula weight. A useful API assessment combines identity and assay with impurities, residual solvents and physical characteristics. Finished-product suitability depends on the complete specification and the manufacturing process, rather than on assay alone.
Product Identity & Specifications
Chemical identity, physical characteristics and key specifications for Ciprofloxacin Hydrochloride.
| Parameter | Description / value | Basis / application |
|---|---|---|
| Product identity | Ciprofloxacin hydrochloride | Hydrochloride salt |
| Anhydrous formula | C₁₇H₁₈FN₃O₃·HCl | Excludes water |
| Anhydrous molar mass | 367.81 g/mol | Salt basis |
| Monohydrate CAS | 86393-32-0 | Identity in USP preview |
| Monohydrate mass | 385.82 g/mol | One molecule of water |
| Sesquihydrate mass | 394.83 g/mol | One and a half molecules of water |
| Published assay | 98.0–102.0% | USP, anhydrous hydrochloride basis |
| Water / hydrate state | Variable water content | Define the purchased form |
| Physical presentation | Solid API | Appearance and colour in specification |
| Particle distribution | Specified sieve or laser-diffraction profile | Dosage-form development |
| Related substances | Individual and total impurity limits | Chosen API standard |
| Residual solvents | Route-specific profile | Manufacturer quality documentation |
Identity and published standard
USP–NF: Ciprofloxacin Hydrochloride
The published definition specifies 98.0–102.0% ciprofloxacin hydrochloride on the anhydrous basis and recognises variable water content.
View published monographA published standard describes the material; conformity of the offered grade is confirmed through its current specification and COA.
For further information and current COA/specification, please contact us.
Request current COA & specificationApplications & functional benefits
Oral solid products
Used in qualified ciprofloxacin dosage-form manufacture. Particle properties, potency correction and excipient compatibility should be matched to the intended process.
Formulation development
Suitable for development programmes requiring an identified hydrochloride grade. The final product must establish its own uniformity, dissolution and stability performance.
Source qualification
A defined specification supports comparison of potential manufacturers. Include the intended market and documentation requirements when requesting a sample or commercial offer.
Hydrochloride forms and procurement choices
| Grade / form | Main distinction | Selection consideration |
|---|---|---|
| Anhydrous hydrochloride | 367.81 g/mol | Specify water limits and assay basis. |
| Monohydrate | 385.82 g/mol | Use the monohydrate identity in the requirement. |
| Other hydrated hydrochloride | Water contribution differs | Review the offered hydrate form and current COA. |
Formulation & processing
Align salt and dose calculations
A product strength expressed as ciprofloxacin requires a calculation consistent with the hydrochloride form and actual potency. Follow the approved formula and avoid applying water corrections twice.
Evaluate physical properties
Agree particle distribution and bulk behaviour for the intended manufacturing equipment. A fine-powder description does not replace a measured distribution.
Control quality through qualification
Review degradation products, residual solvents, analytical methods and stability information. Sterile-use suitability must be established separately where relevant.
What to check in the specification
- Identity and active-content assay, with calculation basis
- Related substances and degradation products
- Water content and residual solvents
- Particle-size requirements for the intended manufacturing process
Current product documentation
Request the current batch COA, full specification and SDS. Stability/retest information, impurity details and manufacturer regulatory documentation can be discussed for your qualification requirements.
Request documents for Ciprofloxacin HydrochloridePacking, storage & handling
Packing and quotation details
Discuss the required net weight, sample quantity and delivery schedule with SBS. Packaging should be compatible with the material and carry product, manufacturer and batch identification. Confirm the offered pack size and shelf-life or retest information in the quotation; these depend on the selected grade.
Storage and safe handling
Keep containers closed and protected from contamination. Follow the offered manufacturer’s labelled storage conditions and retest date; use its SDS for handling controls.
Frequently asked questions
Is ciprofloxacin hydrochloride the same as ciprofloxacin base?
It contains the same active moiety as a hydrochloride salt. Identity, molecular mass and formulation calculations differ from the free base.
Why is water content listed separately?
The salt may contain variable water. Water testing and the assay basis together clarify the effective material content.
What documents can I request?
Ask for the current COA, full specification, SDS, impurity information and available manufacturer qualification documents.
Technical information sources
Need more information?
Contact SBS for further product details, current COA, specification, packing and a quotation for your requirement.
Contact SBS for details and documents