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Metformin Hcl Extract Powder

【English name】: Metformin Hydrochloride
【Other Name】: Metformin HCL
【CAS No.】:1115-70-4
【Molecular Formula】: C4H12ClN5
【Molecular Weight】: 165.62
【Specification】: Min 99%
【Appearance】: White Crystalline Powder
【Solubility】: Water-soluble
【Grade Standard】: Medicine Grade
【Usage】: Animal Pharmaceuticals

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Metformin HCl Extract Powder - Pharmaceutical Grade API

You've come to the right place. Our product delivers Min 99% purity, manufactured through strict pharmacopoeia standards. Metformin Hcl Extract Powder is synthesized from dicyandiamide and dimethylamine hydrochloride beneath controlled conditions. It shows up as white crystalline powder, water-soluble, and steady over different handling temperatures. Whether you require it for tablets, capsules, or verbal fluids, our pharmaceutical-grade fabric meets ChP/USP/EP guidelines with full clump traceability.

Product Specifications

Parameter	Details
English Name	Metformin Hydrochloride
CAS No.	1115-70-4
Molecular Formula	C4H12ClN5
Molecular Weight	165.62
Specification	Min 99%
Appearance	White Crystalline Powder
Melting Point	221~226°C
Water Solubility	~350 g/L at 25°C
pH Stability Range	2.0 ~ 9.0
Moisture Content	≤0.3%
Particle Size	60–300 mesh (customizable)
Grade	Pharmaceutical Grade
Packaging	25kg/drum, double-layer PE + cardboard

Why Choose Shaanxi Rebecca Bio-Tech?

· Strong R&D Team: Experienced researchers specializing in pharmaceutical ingredients

· Large-Scale Capacity: 3 production lines, 2,000+ tons annual capacity

· Advanced Testing Lab: UPLC, HPLC, GC-MS, ICP-MS equipped

· GAP-Based Management: Strict control of pesticide residues and heavy metals

· Global Support: Professional international marketing and after-sales service

· Custom Solutions: OEM/ODM available, flexible formulations

Certification Analysis of Metformin Hydrochloride Extract Powder

Test Item	Specification	Test Result	Test Method
Appearance	White crystalline powder, odorless	White crystalline powder	Visual Inspection
Identification	Meets USP identification requirements	Complies	USP / Infrared Spectroscopy
Assay (Metformin Hydrochloride)	99.0% ~ 101.0%	99.56%	HPLC
Loss on Drying	≤0.5%	0.21%	Constant Temperature Drying Method
Residue on Ignition	≤0.1%	0.04%	Gravimetric Method
pH (5% Aqueous Solution)	6.8 ~ 8.2	7.42	Precision pH Meter
Related Substances (Single Impurity)	≤0.1%	0.03%	HPLC
Total Related Impurities	≤0.3%	0.08%	HPLC
Lead (Pb)	≤1.0 ppm	＜0.10 ppm	ICP-MS
Arsenic (As)	≤1.0 ppm	＜0.10 ppm	ICP-MS
Cadmium (Cd)	≤0.5 ppm	＜0.05 ppm	ICP-MS
Mercury (Hg)	≤0.1 ppm	＜0.01 ppm	ICP-MS
Residual Solvents	Complies with USP residual solvent limits	Not Detected	GC-MS
Total Aerobic Microbial Count	≤1000 CFU/g	95 CFU/g	Microbiological Culture Method
Mold & Yeast Count	≤100 CFU/g	12 CFU/g	Microbiological Culture Method
Escherichia coli	Negative per g	Negative	Microbiological Test
Salmonella	Negative per 10g	Negative	Microbiological Test

Source and Traceability You Can Trust

Starting Materials

Our item starts with chemical/pharmaceutical-grade dicyandiamide and dimethylamine hydrochloride. Each crude fabric bunch experiences pre-use testing. The supply chain is develop and steady, sourced from certified pharmaceutical and chemical clusters in Shandong, Jiangsu, Zhejiang, and Hebei territories.

Two Clear Grades

Pharmaceutical Grade(Our Standard):

· Meets pharmacopoeia standards

· Suitable for oral solid and liquid dosage forms

· Mainstream in pharmaceutical market

· Full regulatory compliance

Industrial Grade(Not Our Product):

· Relaxed purity standards

· Only for chemical synthesis

· Strictly prohibited in pharmaceuticals and food

Solubility Profile

Solvent Type	Solubility Characteristics
Water	Extremely soluble (~350 g/L at 25°C), colorless, transparent
Methanol/Ethanol	Soluble, lower than water
Isopropanol	Slightly soluble
Ether/Acetone/Oils	Almost insoluble

Application Tip: For fluid definitions, watery stage frameworks work best. Oil-based frameworks cannot straightforwardly join this fabric.

Stability Characteristics

Thermal Stability

· Solid Form: Stable up to 150°C during tableting, granulation, spray drying

· Aqueous Solution: Stable at 100°C short-term boiling; avoid prolonged high-temperature reflux

Acid-Base Stability

· Safe Range: pH 2.0 ~ 9.0

· Avoid prolonged exposure to pH < 1.5 or > 9.5 with heating

Light and Oxygen Stability

· Solid API: Room temperature storage, light-protected, sealed; no sensitivity to light/oxygen

· Aqueous Solutions: Must be stored light-protected and sealed to prevent yellowing

Manufacturing Process Excellence

Our 11-step pharmaceutical-grade production ensures the highest quality Metformin Hcl Extract Powder:

Step	Process	Key Control
1	Raw Material Batching	Strict molar ratios, pre-use testing
2	High-Temperature Condensation	115–125℃ for 4–6h, HPLC monitoring
3	Cooling Crystallization	45–55℃ slow crystal growth
4	Alkali Purification	Critical impurity removal step
5	Acidification & Salt Formation	Pharmaceutical-grade HCl, precise pH
6	Ethanol Recrystallization	Most Critical: 65℃→15℃ gradient cooling
7	Centrifugation & Rinsing	High-speed separation, ethanol spray
8	Vacuum Drying	55–65℃, 12–16h, moisture ≤0.3%
9	Grinding & Sieving	60–300 mesh classification
10	Quality Inspection	HPLC testing, metal detection, COA
11	Aseptic Packaging	Double-layer PE + drum, <60% humidity storage

Tips:
Step 6 - Ethanol Recrystallization is the center prepare that recognizes pharmaceutical-grade from industrial-grade items, completely expelling dicyandiamide, dimethylamine, obscure pollutions, and remaining solvents.

Products Description

Our certification system provides multiple safeguards for building your market confidence:

Quality Assurance

· Full batch traceability from raw materials to finished product

· UPLC, HPLC, GC-MS, ICP-MS analytical testing

· ISO9001, cGMP, HACCP, FSSC22000 certified

· Monthly production capacity: tens of tons

· COA provided with each batch

· Third-party tested for purity, potency, heavy metals

Flexible Packaging & Delivery

Standard Packaging:

· 25kg/drum with double-layer sterile PE inner bag

· Thickened export cardboard drum

· Moisture-proof, waterproof, damage-proof

Custom Options: 1kg aluminum foil bags, other sizes available

Delivery Methods: FedEx, DHL, air freight, sea freight

FAQ

Q: What are the send out bundling determinations? Is it moisture-proof and waterproof?

A: Standard send out bundling is 25kg/drum, with a double-layer sterile PE inward sack + thickened trade cardboard drum, moisture-proof, waterproof, and damage-proof, reasonable for ocean, discuss, and long-distance transportation.

Q: Is the item clump traceable?

A: Full clump administration, with total crude fabric traceability, generation records, hardware records, quality review records, and test maintenance records, assembly the necessities for abroad medicate administrative inspections.

Q: What is the month to month generation capacity? Can you supply huge amounts stably?

A: Adequate generation capacity, tens of tons per month, with promptly accessible stock, empowering long-term steady supply of abroad orders and supporting yearly system cooperation.

Q: What are the appearance characteristics over diverse batches?

A: This item is a white crystalline powder, odorless and severe. Standardized generation handle control guarantees uniform color over clumps, with no yellowing or discoloration.