For pharmaceutical use, Saroglitazar Magnesium is the important marketed salt form, so I recommend using Saroglitazar Magnesium (CAS 1639792-20-3) as the primary API form rather than the free acid. FDA substance records identify the magnesium salt as a 2:1 salt of saroglitazar, with formula C₅₀H₅₆MgN₂O₈S₂ and molecular weight 901.43 g/mol.
Saroglitazar Magnesium is a synthetic PPARα/γ agonist belonging to the glitazar class of metabolic drugs. It has predominant PPARα activity with additional PPARγ activity and has been developed for metabolic disorders involving lipid and glucose metabolism. The active moiety, saroglitazar, has CAS 495399-09-2, while the pharmaceutical magnesium salt has CAS 1639792-20-3.
In India, Saroglitazar Magnesium has been approved for indications including diabetic dyslipidemia, hypertriglyceridemia, type 2 diabetes mellitus as an add-on to metformin, and non-alcoholic fatty liver disease (NAFLD). Zydus reported DCGI approval for type 2 diabetes in 2020 and NAFLD in the same year.
The compound acts through activation of peroxisome proliferator-activated receptors. PPARα activation contributes to regulation of lipid metabolism, while PPARγ activity contributes to effects on glucose and insulin sensitivity. PubChem classifies saroglitazar as a PPARα and PPARγ agonist.
| Parameter | Details |
|---|---|
| Product Name | Saroglitazar Magnesium |
| Active Moiety | Saroglitazar |
| CAS Number | 1639792-20-3 |
| Active Moiety CAS | 495399-09-2 |
| UNII | K8V5DLS63R |
| Molecular Formula | C₅₀H₅₆MgN₂O₈S₂ |
| Molecular Weight | 901.43 g/mol |
| Salt Ratio | Magnesium salt, 2:1 saroglitazar:Mg |
| Drug Class | PPARα/PPARγ agonist |
| Therapeutic Area | Metabolic disorders |
| Stereochemistry | Defined S configuration |
| Active Moiety Formula | C₂₅H₂₉NO₄S |
| Active Moiety Molecular Weight | 439.60 g/mol |
The formula, CAS number, stereochemical definition and molecular weight are supported by FDA's Global Substance Registration System and PubChem.
Saroglitazar Magnesium has been used/developed in pharmaceutical products for metabolic conditions, particularly:
Zydus reports that Saroglitazar Magnesium was initially approved in India for hypertriglyceridemia and diabetic dyslipidemia, followed by approval for type 2 diabetes and NAFLD.
I have not inserted unsupported assay, impurity, water or LOD numerical limits for Saroglitazar Magnesium. FDA identifies the substance and its chemical identity, but I did not find a current authoritative public USP/Ph. Eur. monograph establishing universal numerical release limits for this API. Therefore, these parameters should be taken from the approved product/API specification rather than presented as pharmacopoeial limits.
A pharmaceutical-grade Saroglitazar Magnesium quality-control program should address:
Because Saroglitazar Magnesium contains a defined stereocenter and is a 2:1 magnesium salt, control of both stereochemical identity and salt form is important. FDA's substance record confirms two defined stereocenters for the complete magnesium salt representation.
Saroglitazar Magnesium is an important pharmaceutical ingredient in India's metabolic-disease sector. Its development and regulatory history in India includes applications for diabetic dyslipidemia, hypertriglyceridemia, type 2 diabetes and NAFLD.
A pharmaceutical manufacturing program for Saroglitazar Magnesium should maintain controlled raw materials, validated manufacturing processes, analytical testing, batch traceability and appropriate quality documentation.
The exact salt form should always be clearly identified as Saroglitazar Magnesium, CAS 1639792-20-3, rather than using the free-acid CAS number 495399-09-2 as the primary product identifier.
Saroglitazar Magnesium should be packed in suitable pharmaceutical-grade, well-closed packaging designed to protect the material from moisture, contamination and unsuitable environmental exposure.
Storage conditions should be based on validated stability data and the approved product specification. A universal storage temperature should not be stated unless supported by the applicable stability documentation.
Typical pharmaceutical documentation can include:
Saroglitazar Magnesium is a defined pharmaceutical salt of the PPARα/γ agonist saroglitazar with an established identity, CAS number and molecular characterization. Its clinical and regulatory development in India has focused on metabolic disorders including diabetic dyslipidemia, type 2 diabetes and NAFLD.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |