Description

Ziprasidone Hydrochloride Monohydrate is the monohydrate salt form of ziprasidone, an atypical antipsychotic agent. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers for the production of solid oral dosage forms, such as capsules and tablets, used in the treatment of schizophrenia and bipolar disorder.

Application

• Pharmaceutical API: Primary use as the active ingredient in the manufacture of antipsychotic medications.
• Generic Drug Production: Serves as a key component for generic pharmaceutical companies developing bioequivalent versions of branded antipsychotics.
• Dosage Form Development: Used in R&D and scale-up for formulating capsules, tablets, and other solid oral dosage forms.
• Clinical Trial Material: Supplied as a reference standard or raw material for the production of drugs used in clinical research studies.
• Analytical Reference Standard: Employed in quality control laboratories for method development, validation, and routine testing via HPLC or other chromatographic techniques.

Basic Information

Product Name	Ziprasidone Hydrochloride Monohydrate
CAS No.	138982-67-9
Molecular Formula	C21H22Cl2N4OS • HCl • H2O
Molecular Weight	467.82 g/mol (Monohydrate)
Synonyms	5-[2-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one hydrochloride monohydrate; Zeldox; Geodon (brand name salt form); Ziprasidone HCl Monohydrate; 138982-67-9; CP-88059-1
EINECS	Contact for details

Quality Control

Our Ziprasidone Hydrochloride Monohydrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting results for assay, related substances, residual solvents, water content, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. The original container should be kept sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC, anhydrous basis)	98.0% - 102.0%
Water Content (KF)	3.0% - 5.0%
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	< 20 ppm
Sulfated Ash	< 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.