PRL-8-53 API — Technical Data Sheet

1. Substance identity

2. Longshine Boi-Tech offerings for PRL-8-53

Memory-enhancement research compound PRL-8-53 — high-purity analytical reference standard. Purity 98% min. Molecular formula C18H21NO2. Physical form: White or off-white powder. CAS Registry Number: 51352-87-5. Supplied in 100g, 500g, 1kg+ quantities from $2.00/g entry for laboratory research, analytical method development, and reference-standard applications. Research use only — not for human or animal consumption.

We supply PRL-8-53 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

PRL-8-53 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:

• Assay — typically ≥ 98.0% (HPLC) for catalogue grade; ≥ 99.0% on customer-specific spec.
• Related substances — individual and total impurities reported against ICH Q3A thresholds.
• Water content — Karl Fischer or Loss on Drying, per monograph.
• Heavy metals — ICH Q3D-compliant elemental impurity testing.
• Residual solvents — Gas Chromatography against ICH Q3C class limits.
• Particle-size distribution — laser diffraction, with D10/D50/D90 reported.
• Microbial limits / bacterial endotoxin — where the monograph requires.

4. Impurity profile & stability

Each PRL-8-53 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 PRL-8-53 (or compatible LoA support):

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

• Primary packaging — Food-grade LDPE bag inside an HDPE drum, vacuum-sealed with desiccant where the molecule requires moisture exclusion. Tare and gross weights printed on the secondary label.
• Pack sizes — 1 kg, 5 kg, 25 kg, and 50 kg drums standard. Custom pack sizes available on negotiation.
• Storage — Default storage at 2-8°C, 15-25°C, or controlled-room temperature per the molecule's stability dossier. Storage requirement printed on every drum and the shipping documentation.
• Air-freight shipping — Pune (Mumbai BOM) to North America: 4-5 days door-to-door. To Europe: 3-4 days. To LATAM: 4-6 days. To East Asia: 2-3 days.
• Sea-freight shipping — JNPT to US East Coast: 18-25 days. To Northern Europe: 22-28 days. To Brazil: 25-30 days.
• Incoterms — EXW, FCA, CIP, CFR, DAP, DDP all supported per buyer's preference.

7. Commercial supply terms

• Minimum order quantity — molecule-specific, typically 1-5 kg for stocked APIs and 25 kg for the cost-down tier.
• Lead time — 7-10 business days for stocked APIs against confirmed PO; 4-8 weeks for custom synthesis or scale-up campaigns.
• Payment terms — 30% advance plus 70% against shipping documents for new customers; net-30 to net-90 against trade-credit-insured invoice or irrevocable LC for established customers. USD, EUR, GBP, INR supported.
• Quality guarantee — 12-month replacement guarantee against any material released that fails the buyer's incoming-goods inspection on the agreed specification.
• Confidentiality — Mutual NDA executed before any technical disclosure or DMF reference is shared.