Zofenopril Calcium is a pharmaceutical active pharmaceutical ingredient belonging to the angiotensin-converting enzyme (ACE) inhibitor class. It is the calcium salt of zofenopril and functions as a prodrug that is converted in the body to the active metabolite zofenoprilat. Zofenoprilat inhibits ACE, reducing the conversion of angiotensin I to angiotensin II and thereby producing vasodilatory and antihypertensive effects.
Zofenopril Calcium is therefore an important cardiovascular pharmaceutical API used in the development and manufacture of medicines for hypertension and related cardiovascular applications.
The correct CAS Number for Zofenopril Calcium is 81938-43-4. PubChem identifies its molecular formula as C44H44CaN2O8S4 and molecular weight as 897.2 g/mol. The FDA Global Substance Registration System identifies the substance with UNII 88ZQ329PU2.
Zofenopril Calcium is the hemicalcium salt of zofenopril. The substance consists of two zofenopril anions associated with one calcium ion. Its chemical structure contains a proline-derived ring system, phenylthio functionality and benzoylthio functionality.
Zofenopril is the parent prodrug, while zofenoprilat is the active metabolite responsible for ACE inhibition. Zofenopril Calcium is converted through hydrolysis to active zofenoprilat following administration.
This distinction is important when preparing an API product page because Zofenopril Calcium, Zofenopril and Zofenoprilat are separate chemical substances with different CAS numbers and molecular formulas.
Zofenoprilat competitively inhibits angiotensin-converting enzyme. ACE is responsible for converting angiotensin I into the potent vasoconstrictor angiotensin II.
Reduction of angiotensin II formation decreases vasoconstriction and reduces aldosterone secretion. This contributes to reduced vascular resistance and increased sodium and water excretion, supporting the antihypertensive action of the drug.
Zofenopril is also notable among ACE inhibitors because the active molecule contains a sulfur-containing functionality, which is associated with its pharmacological and chemical characteristics.
Zofenopril Calcium is a crystalline pharmaceutical solid. Available commercial chemical references describe it as a white to light-yellow powder or crystalline material.
Zofenopril Calcium can occur in different crystalline forms and hydrated states. Patent literature describes polymorph A and other forms, including a monohydrate form. This solid-state behavior is relevant to pharmaceutical API manufacturing because polymorphic form and hydration state can affect stability, processing and analytical properties.
Polymorphism is an important quality attribute of Zofenopril Calcium. Published patent literature describes crystalline forms and identifies polymorph A through XRPD characterization. Other patent literature describes Zofenopril Calcium monohydrate with a melting range around 244–248°C and HPLC chemical purity of approximately 99.5–99.7% in the reported examples.
Therefore, XRPD and related solid-state analytical methods can be useful during API development and manufacturing to confirm the intended crystalline form.
Zofenopril Calcium is manufactured through chemical synthesis followed by formation of the calcium salt. Published process literature describes conversion of zofenopril salt/intermediate material with calcium chloride followed by filtration, washing and controlled drying.
Manufacturing control is particularly important because Zofenopril Calcium has multiple stereochemical centers and can exist in different solid-state forms.
The final API is typically evaluated for identity, assay, related substances, moisture, inorganic residues, residual solvents and other applicable quality characteristics.
A published pharmaceutical API specification reports an assay range of 99.0–101.0% on an anhydrous basis. The same source reports an actual example assay of 99.8%.
This value is appropriate as a reference API specification for the SDP product page. It should not be described as a current USP/BP monograph requirement unless the specific applicable pharmacopoeial monograph is being used.
Related-substance control is an important part of Zofenopril Calcium API quality. The available pharmaceutical API specification reports unspecified individual impurities NMT 0.10% each and total impurities NMT 0.50%.
HPLC is appropriate for monitoring chemical purity and related substances. Published process examples demonstrate HPLC purity values above 99% for Zofenopril Calcium.
The published API specification gives water NMT 1.0% and loss on drying NMT 2.0%.
Moisture control is important because Zofenopril Calcium can occur in hydrated and different crystalline forms. Manufacturing and storage conditions should therefore be controlled to maintain the intended physical form and chemical quality.
The available pharmaceutical API specification reports residue on ignition NMT 0.10% and heavy metals NMT 10 ppm. Sulphated ash is separately reported at NMT 0.50%.
These tests provide additional control of inorganic residues and elemental contaminants associated with manufacturing and raw materials.
Available chemical references show that Zofenopril Calcium has limited aqueous solubility and is soluble in selected organic solvents. One current research-grade source reports solubility in DMSO and insolubility in methanol, while other reference descriptions vary depending on experimental conditions and material form.
For a pharmaceutical product page, it is therefore preferable not to make an overly broad solvent-solubility claim without specifying the test conditions.
Published patent literature reports Zofenopril Calcium melting behavior around 235–246°C for certain crystalline forms, with DSC endotherms extending into the approximately 254–258°C range. A separate monohydrate form is reported at approximately 244–248°C.
Commercial analytical references also report melting points around 246°C or 249–251°C, demonstrating that the observed value can depend on crystal form, hydration and analytical method.
For this reason, melting point should be treated as a physicochemical reference value rather than a universal release specification.
Zofenopril Calcium is associated with cardiovascular pharmaceutical applications as an ACE inhibitor prodrug. Following conversion to zofenoprilat, ACE inhibition reduces angiotensin II formation and supports reduction of blood pressure.
Its pharmaceutical API characteristics make it relevant to formulation development, analytical testing and commercial pharmaceutical manufacturing.
A comprehensive quality-control program for Zofenopril Calcium can include IR identification, HPLC identification and assay, related-substance testing, water or loss-on-drying determination, residue on ignition, heavy metals, residual solvents, calcium identification/content and solid-state characterization.
Because the API is stereochemically defined and polymorphic, appropriate control of stereochemical purity and crystalline form is also important.
Zofenopril Calcium is a specialized cardiovascular API suitable for pharmaceutical development and manufacturing applications. B2B API sourcing typically requires appropriate analytical documentation, specification compliance, certificate of analysis and supporting quality documentation.
For the SDP product page, relevant commercial search terms include Zofenopril Calcium API Manufacturer, Zofenopril Calcium API Supplier, Zofenopril Calcium Manufacturer India, Zofenopril Calcium Supplier India, ACE Inhibitor API Manufacturer and Cardiovascular API Supplier India.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–101.0% (anhydrous basis) |
| Loss on Drying | NMT 2.0% |
| Residue on Ignition | NMT 0.10% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 1.0% |
| Melting Point | 235–251°C |