Nalbuphine Hydrochloride API — Technical Data Sheet

1. Substance identity

2. Longshine Boi-Tech offerings for Nalbuphine Hydrochloride

Nalbuphine Hydrochloride is a synthetic mixed agonist-antagonist opioid analgesic — kappa-opioid receptor agonist with mu-opioid receptor antagonist activity. Manufactured to USP monograph specifications. Ceiling effect on respiratory depression makes it useful for post-operative pain and obstetric analgesia where full mu-agonist safety margin is a concern. Not federally scheduled in US — state-level scheduling varies.

We supply Nalbuphine Hydrochloride to human apis 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

Nalbuphine Hydrochloride 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 Nalbuphine Hydrochloride 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 Nalbuphine Hydrochloride (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.