99% Spectinomycin HCl API Of GMP Factory
Spectinomycin hydrochloride API often exists as the pentahydrate.
It is an antibiotic commonly used against gram-negative bacteria and used to treat gonorrhea.
Our Spectinomycin Hydrochloride API is manufactured in a GMP‑compliant facility with strict control over related substances, residual solvents, and particle size.
It is suitable for sterile injectable solutions (human: 2 g vials; veterinary: 100 mg/mL and 250 mg/mL), oral solutions (poultry and swine), and compounded formulations.
Why Import Our Spectinomycin HCl API
#1. High Quality In Compliance With cGMP:
The bulk spectinomycin API powder is produced and packed strictly in accordance with cGMP requirements.
This type of raw material is suitable for medicine manufacturing, pharmacy compounding, etc.
Manufacturer Certificates Available: GMP/ISO/DML
Supplier Documents Available: COA/MSDS/DMF
#2. Different Packing Sizes and Materials:
As one of our GMP APIs, it is available in standard packing sizes of 25kg/carton, 10kg/carton, and 1kg/carton.
If you need less than our minimum order quantity, we can repack 100G, 200G, or 500G to meet your packing requirements.
Foil bags and tins are available for packing materials. Choose the one you need, and we will prepare it accordingly.
Spectinomycin HCL Applications and Specifications
Applications:
Spectinomycin HCl API is used in the following pharmaceutical and compounding applications:
Sterile injectable solution (human) – for the treatment of uncomplicated gonorrhea (single intramuscular dose of 2 g for men and 4 g for women, often combined with 1 g oral probenecid to enhance blood levels). Branded as Trobicin®.
Sterile injectable solution (veterinary) – for the treatment of bovine respiratory disease (BRD), swine respiratory disease (SRD), and calf diarrhea. Typical dosage: 10–20 mg/kg IM.
Oral soluble powder (veterinary) – for poultry and swine via drinking water for the treatment of colibacillosis, mycoplasmosis, and chronic respiratory disease (CRD). Typical concentration: 0.5–1 g per liter of water.
Combination injectables (veterinary) – with lincomycin (e.g., Linco‑Spectin®) for enhanced Gram‑positive and Gram‑negative coverage, or with tylosin for mycoplasma and respiratory infections.
Compounded oral suspensions (veterinary) – for exotic animals or custom dosing in small animal practice when commercial products are unavailable.
Compounded ophthalmic solutions – for the treatment of gonococcal ophthalmia neonatorum (off‑label, limited use).
For compounding pharmacies: Our Spectinomycin HCl API is available in sterile and non‑sterile grades, with custom packaging from 1 g to 100 g. We provide full stability data for injectable reconstitution, oral solutions, and water‑based formulations.
Product Name: Spectinomycin Hydrochloride API (Spectinomycin dihydrochloride pentahydrate, spectinomicina clorhidrato, 盐酸大观霉素)
Appearance: A white to light yellow crystalline powder
Solubility: Very soluble in water, about 1 gram/7 L. It is also soluble in methanol, propylene glycol, formamide, DMSO, 0.1 N HCl, and 0.1 N NaOH. However, it’s almost insoluble in alcohol, chloroform, or ether.
Cas Number: 22189-32-8
Molecular Formula: C14H24N2O7·2HCl·5H2O
Molecular Weight: 495.35 g/mol
Chemical Name: (1R,3S,5R,8R,10R,11S,12S,13R,14S)-8,12,14-trihydroxy-5-methyl-11,13-bis(methylamino)-2,4,9-trioxatricyclo[8.4.0.03,8]tetradecan-7-one;pentahydrate;dihydrochloride
HS Code: 2941909099 (Other antibiotics-其他抗菌素)
Suitability to be shipped by air/sea/rail as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharmaceutical Grade
Purity, assay, or potency: No Less Than 603 ug/mg
Standards: USP
Manufacturer Documents Available: COA/MSDS/SDS
Manufacturer Certificates Available: Local GMP/ISO/WC
Supply Capability: Over 100 KG per month
MOQ: 1000 G
Spectinomycin HCl API Price Ideas in 2025: $ 400/KG for 1 KG, including shipping cost. (Contact us by WhatsApp for more updated prices)
Lead Time: 3~4 days for quantities less than 50 KG
Stock Status: Over 500 KG
Shipping Temperature: Room temperature
Storage: 2~8 °C
Why Choose Us as Your Spectinomycin HCl API Supplier?
Pharmaceutical manufacturers, veterinary compounding pharmacies, and generic drug developers select us for these five key advantages:
1. High Purity & Strict Quality Control
Assay (on anhydrous basis): 98.0% – 102.0% (USP/EP)
Single largest impurity (spectinomycin related compound A – actinospectinoic acid): ≤ 1.0%
Total impurities: ≤ 2.0%
Residual solvents meet ICH Q3C limits
Full batch‑by‑batch COA, HPLC chromatograms, and stability data available
2. Sterile & Non‑Sterile Grades
Sterile injectable grade – sterile filtered, pyrogen‑tested, filled in 2 g, 4 g, 10 g vials (human and veterinary use)
Veterinary compounding grade (non‑sterile) – bulk powder for oral solutions, feed additives, and water‑based treatments
Research grade – for R&D and analytical purposes
3. Scalable Supply for Commercial & Compounding Volumes
Annual production capacity: 100+ metric tons
Lead time: 7–10 days for non‑sterile grades; 14–21 days for sterile vials
All packaging includes desiccated, moisture‑barrier materials
Regional warehouses in North America, Europe, Asia, and South America
4. Regulatory & Technical Documentation
DMF Type II (US, Canada, EU, China, Brazil) available for cross‑reference
Complete impurity profile, including forced degradation and photostability studies
Technical support for formulation: compatibility with water (pH adjustment), stability in combination with lincomycin, tylosin, or other veterinary antibiotics, and pH‑dependent solubility optimization
5. Compounding‑Friendly Policies
Low MOQ: 5 g for non‑sterile veterinary compounding grade (1 g trial size available)
Free R&D samples (up to 1 g) for licensed compounding pharmacies
Stability protocols and beyond‑use dating (BUD) guidance for reconstituted injectable solutions and oral drinking water preparations
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