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Spectinomycin HCl (Hydrochloride)

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Spectinomycin Hydrochloride molecular structure
Quick Facts
CAS Number22189-32-8
Molecular FormulaC14H24N2O7 · 2HCl · 5H2O
Molecular Weight495.35
PharmacopoeiaUSP/IN HOUSE/EP
Packaging25 KG/DRUM
GMP Certified FDA: VMF 005884 CEP: 2024-135-REV 00

Product Overview

Spectinomycin hydrochloride was discovered in 1961 by Mason, Dietz, and Smith at Upjohn Laboratories from the soil bacterium Streptomyces spectabilis. Unlike aminoglycosides such as gentamicin or neomycin, spectinomycin is a pure aminocyclitol — it lacks the amino sugar residues that contribute to nephrotoxicity and ototoxicity. This structural difference is why spectinomycin is the safest injectable antibiotic in the aminoglycoside-related class, with no requirement for therapeutic drug monitoring.

In poultry production, spectinomycin has been a standard treatment for chronic respiratory disease (CRD) since the 1970s. Its unique advantage over other aminoglycosides is measurable oral bioavailability — approximately 7% in adult animals and significantly higher in day-old chicks and piglets — making it effective via drinking water administration. Competing antibiotics like gentamicin remain largely confined to the gut lumen after oral dosing and cannot achieve systemic levels.

The spectinomycin + lincomycin fixed-dose combination, marketed internationally as Lincospectin and in China as Qinligao, pairs spectinomycin's Gram-negative and Mycoplasma coverage with lincomycin's Gram-positive and anaerobic spectrum. This combination covers the four major pathogen groups encountered in poultry and swine respiratory disease, making it one of the most widely prescribed veterinary antibiotic formulations in Asia, Latin America, and the Middle East.

As of mid-2026, global spectinomycin demand is driven by expanding poultry production in Southeast Asia and Africa, where CRD remains the most economically damaging respiratory disease. China accounts for the dominant share of global spectinomycin API production, with manufacturing concentrated in Shandong and Jiangsu provinces. KingWish supplies GMP-certified spectinomycin HCl backed by FDA VMF 005884 and CEP 2024-135-REV 00, supporting veterinary pharmaceutical manufacturers in regulated and emerging markets.

Quality Specifications

Purity (HPLC)≥ 98.0% (anhydrous basis), per USP/EP monograph
Related SubstancesIndividual impurity ≤ 0.5%, total impurities ≤ 2.0% (USP)
Residual SolventsCompliant with ICH Q3C; ethanol ≤ 5,000 ppm
Heavy Metals≤ 20 ppm
GMP StatusManufactured under ICH Q7 GMP conditions
Regulatory FilingsFDA VMF 005884 (active) | CEP 2024-135-REV 00 (valid)

Veterinary Applications

Soluble Powder (Poultry)

Spectinomycin 40g + Lincomycin 20g per 100g. Drinking water: 0.5-0.8g/L for 3-5 days. Injection: one bottle per 2,000-3,000 day-old chicks.

Injectable Solution

10ml: 0.5g (500,000 IU). Intramuscular injection for dogs: 0.2-0.3ml/kg, twice daily for 3 days.

Therapeutic Areas

  • Poultry: E. coli infections, salmonellosis, chronic respiratory disease (CRD)
  • Swine: Bacterial enteritis, pasteurellosis, mycoplasmal pneumonia
  • Companion Animals: Bacterial infections susceptible to spectinomycin

Sourcing Spectinomycin HCl: Key Checks

Documentation

Request CoA with HPLC purity data, residual solvent statement (ICH Q3C), and GMP certificate. For regulated markets, verify VMF/DMF or CEP filing status with the supplier before placing a purchase order.

Red Flags

Inconsistently high impurity peaks on HPLC, reluctance to share batch CoA before order, vague pharmacopoeia claims ("meets USP" without test data), and prices significantly below market range.

Packaging & Logistics

Standard: 25 KG/DRUM. Custom packaging available. Verify storage conditions (room temperature, protected from moisture). Standard lead time 4–8 weeks depending on regulatory documentation requirements.

Market Context

Global spectinomycin market projected to grow steadily through 2035 driven by poultry production expansion in Southeast Asia and Africa. China dominates API production (>70% global supply). FDA VMF and CEP certifications differentiate Tier-1 suppliers from commodity producers. Market report

Frequently Asked Questions

Spectinomycin HCl is primarily used in poultry for chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and secondary E. coli infections. It is also used in swine for bacterial enteritis and pasteurellosis, and in companion animals for susceptible bacterial infections. The standard poultry protocol is 0.5–0.8 g/L in drinking water for 3–5 consecutive days.
Three key differences: (1) Spectinomycin has measurable oral absorption (~7% in adults, higher in neonates), while gentamicin and neomycin remain largely in the gut after oral dosing — this makes spectinomycin effective via drinking water. (2) Spectinomycin has the lowest nephrotoxicity and ototoxicity risk in its class — it is the only aminoglycoside-related antibiotic that does not require therapeutic drug monitoring. (3) Spectinomycin has consistent activity against Mycoplasma species, while gentamicin and neomycin show poor mycoplasma coverage.
Spectinomycin covers Gram-negative bacteria and Mycoplasma but has limited Gram-positive activity. Lincomycin covers Gram-positive bacteria (Staphylococcus, Streptococcus) and obligate anaerobes. Together they provide broad-spectrum coverage against all major bacterial and mycoplasmal pathogens in poultry and swine. The fixed-dose combination (Lincospectin) typically contains 40 g spectinomycin + 20 g lincomycin per 100 g powder, approved under FDA ANADA #200-407.
For the US market, confirm the supplier holds an active FDA Veterinary Master File (VMF). KingWish holds VMF 005884. For the EU/EEA, a Certificate of Suitability (CEP) from the EDQM is the most important document — KingWish holds CEP 2024-135-REV 00. For other markets, request a GMP certificate (ICH Q7), batch-specific CoA with HPLC data, and residual solvent statement per ICH Q3C. A supplier's willingness to provide these documents before an order is itself a reliability indicator.
Standards: USP/IN HOUSE/EP  |  CAS: 22189-32-8  |  Quality data verified against pharmacopoeia monograph COA and MSDS available  |  DrugBank  |  July 2026

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