Technical data sheet · API offerings

Vinpocetine API — Technical Data Sheet

CAS Registry Number: 42971-09-5 · Therapeutic Category: Nootropics

Vasodilator-class nootropic Vinpocetine — high-purity reference material for laboratory use. Purity 99% min. Molecular formula C22H26N2O2. Physical form: White or pale yellow powder. CAS Registry Number: 42971-09-5. Supplied in 100g, 500g, 1kg+ quantities from…

Contents

  1. Substance identity
  2. Longshine Boi-Tech offerings
  3. Pharmacopoeial specifications
  4. Impurity profile & stability
  5. Regulatory filings & documentation
  6. Packaging, storage & shipping
  7. Commercial supply terms

1. Substance identity

API nameVinpocetine
CAS Registry Number42971-09-5
Therapeutic CategoryNootropics
API TechnologySynthetic / semi-synthetic (molecule-specific route)
Pharmacopoeial referenceUSP · Ph. Eur. · IP · JP — per-buyer specification
ManufacturerLongshine Boi-Tech Pvt. Ltd., Pune, India
Quality systemWHO-GMP · ISO 9001:2015 · ICH Q7 · ICH Q11

2. Longshine Boi-Tech offerings for Vinpocetine

Vasodilator-class nootropic Vinpocetine — high-purity reference material for laboratory use. Purity 99% min. Molecular formula C22H26N2O2. Physical form: White or pale yellow powder. CAS Registry Number: 42971-09-5. Supplied in 100g, 500g, 1kg+ quantities from $0.30/g entry for laboratory research, analytical method development, and reference-standard applications. Research use only — not for human or animal consumption.

We supply Vinpocetine to nootropics buyers across 50+ countries — generic drug manufacturers, CDMOs, hospital pharmacies, research institutions, and contract formulators. Letter of Authorization referencing our active DMF / CEP is issued at no charge to qualified buyers for ANDA, IND, NDA, EU Marketing Authorisation, MHRA UKMA, ANVISA, PMDA, and other regulatory pathways.

3. Pharmacopoeial specifications

Vinpocetine is released against the buyer's chosen pharmacopoeia — USP, Ph. Eur., IP, or JP — with the destination market determining the default. The same lot can carry multiple pharmacopoeial certifications where the monographs align. Specification highlights routinely reported on each Certificate of Analysis (CoA) include:

4. Impurity profile & stability

Each Vinpocetine batch ships with a full impurity profile — identified, qualified, and reported per ICH Q3A and Q3B guidelines. Process-related impurities are characterised in the DMF Restricted Part; degradation products are characterised through forced-degradation studies (acid, base, oxidation, thermal, photolysis) and reported in the stability dossier. ICH-compliant stability data is available on accelerated (40°C / 75% RH) and long-term (25°C / 60% RH or 30°C / 65% RH per ICH zone) conditions — typically 6 months accelerated and 24 to 36 months long-term depending on the molecule. Photostability per ICH Q1B option 2 is included.

5. Regulatory filings & documentation

Active regulatory dossiers maintained for Vinpocetine (or compatible LoA support):

JurisdictionFiling typeDocumentation
United StatesFDA Type II DMFLetter of Authorization within 24 business hours; DMF number disclosed under MNDA
European UnionEDQM CEP or ASMFCEP certificate or ASMF Restricted/Applicant's Part dossier
United KingdomMHRA UKMA / Windsor FrameworkCEP-based recognition; UK-specific reference letter
BrazilANVISA RDC 359/2020Portuguese-language CMC package + reference letter
CanadaHealth Canada DMFCross-reference of US FDA DMF
JapanPMDA J-DMFJP-grade release with Japanese-language label data
KoreaMFDS DMFKP-grade release
GCC regionSFDA dossier supportReference letters and CMC packages

Each CoA carries the manufacturing date, batch number, retest date, and a QR-style traceability identifier linked to the batch manufacturing record. Per ICH Q7 requirements, retain samples are held for two years past the API expiry.

6. Packaging, storage & shipping

7. Commercial supply terms

WHO-GMP & ISO 9001:2015 certified. Active US FDA DMF and EDQM CEP filings. Pharmacopoeial release against USP, Ph. Eur., IP, JP. CoA on every batch. First-shipment lead time 7-10 business days. Letter of Authorization within 24 business hours of supply agreement.
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