Buy Aprotinin / Aprotinin Pharma Grade (Injection) Wholesale- From Umanchimtrade

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Description

If your company is looking for a reliable supplier of pharmaceutical substances and you plan to buy aprotinin in bulk for the production of dosage forms or laboratory purposes, our offer combines high quality and compliance with strict pharmacopoeial standards.

Aprotinin is a polyvalent protease inhibitor, a polypeptide derived from bovine lung tissue. As an active pharmaceutical ingredient (API), it blocks the activity of enzymes such as trypsin, chymotrypsin, kallikrein, and plasmin, forming stable complexes with them. Due to its ability to reduce blood fibrinolytic activity, aprotinin is used in the production of a wide range of hemostatic drugs and agents for the treatment of enzymatic disorders.

Characteristics Table

The actual parameters of the proposed batch, based on laboratory tests (COA), are presented below. The data fully comply with the requirements of the European Pharmacopoeia (EP 11.0).

Characteristic Value / Description

Product Name Aprotinin

English Name Aprotinin

Chemical Formula C284H432N84O79S7

CAS Number 9087-70-1

Molecular Weight ~ 6512 Da

Appearance Almost white powder, hygroscopic

Packaging Standard (hermetic)

EC (EINECS) Number 232-994-9

HS Code (Customs Code) 3504.00

Country of Origin On Request

Certification Complies with EP 11.0

Specification 3.0 Ph.Eur.U./mg

Activity (Actual) 3.40 EPU/mg (6113 KIU/mg)

Melting point > 100 °C

Losses on drying 4.5% (at standard >6.0%)

Aprotinin oligomers 0.27% (at standard Max. 1.0%)

Impurities (Des-Ala-aprotinin) 7.6% (at standard >8.0%)

Impurities (Des-Ala-des-Gly) 7.0% (at standard > 7.5%)

pH (1% solution) 5.8 (normal 5.5–7.0)

Solubility Soluble in water and 0.9% NaCl solution, practically insoluble in organic solvents

Solution appearance Transparent (15 Ph.Eur.U./ml)

Endotoxins >0.14 EU/ Ph.Eur.U. (Complies)

Storage Conditions +2°C to +8°C

Safety and Toxicity Non-toxic (test at 2 Ph.Eur.U./ml)

Aprotinin Specifications and Analysis Results

Quality Index Specification (Requirements) Analysis Result Compliance standard

Activity ≥ 3.0 Ph.Eur.U./mg 3.40 Ph.Eur.U./mg (6113 KIU/mg) Complies

Appearance Almost white powder, hygroscopic Complies Complies

Solution appearance Transparent (15 Ph.Eur.U./ml) Complies Complies

Identification A Positive Conforms Conforms

Identification B Positive Conforms Conforms

pH 5.5 – 7.0 5.8 Complies

Absorbance A≤0.80 (max. absorbance: 277 nm±2 nm; 3.0 Ph.Eur.U./ml) 0.71 Complies

Aprotinin oligomers Max. 1.0% 0.27% Complies

Des-Ala-aprotinin and Des-Ala-des-Gly-aprotinin Impurity A: <8.0%; Impurity B: <7.5% Impurity A: 7.6%; Impurity B: 7.0% Complies

Pyroglutamyl-aprotinin and related compounds Pyroglutamyl-aprotinin: max. 1.0%; Any other impurity: max. 0.5%; Total impurities (except pyroglutamyl-aprotinin): max. 1.0% Pyroglutamyl-aprotinin: 0.58%; Any other impurity: 0.16%, 0.24%, 0.35%; Total impurities: 0.75% Complies

Loss on drying ≤ 6.0% (0.100 g, vacuum dried) 4.5% Complies

Solubility Soluble in water and 0.9% NaCl solution, practically insoluble in organic solvents (5 mg/ml) Complies Complies

Endotoxins ≤ 0.14 EU/Ph.Eur.U. Complies Complies

Pyrogens Absent at 15 Ph.Eur.U./kg (rabbit) Complies Complies

Microbiological purity TAMC: <10 2 CFU/g; TYMC: <10 2
CFU/g; Enterobacteriaceae, Pseudomonas aeruginosa, Staphylococcus aureus: Absence Complies Complies

Abnormal toxicity Non-toxic at 2 Ph.Eur.U./ml Complies Complies

Histamine 0.1 μg histamine base / 3 Ph.Eur.U. Complies Complies

Detailed description and advantages

Our offer Aprotinin is a high-purity lyophilized powder. The official instructions for use (pharmacopeial monograph) describe aprotinin as a substance with potent antiproteolytic activity. The actual activity of our substance is 6113 KIU/mg (kallikrein-inactivating units), which exceeds the minimum standard requirements and guarantees the effectiveness of the final product.
Why choose this raw material:

High purity: The level of aprotinin oligomers is only 0.27%, which is significantly lower than the permissible limit of 1.0%. The total amount of foreign impurities (except for specific isoforms) does not exceed 0.75%.
Stability: The product has passed hygroscopicity and solubility tests. The solution's transparency confirms the absence of denatured protein, which is critical for the production of injectable forms.

Compliance with standards: The substance fully complies with the European Pharmacopoeia monograph (EP 11.0), simplifying the registration of finished medicinal products.

For manufacturing companies interested in aprotinin price, we offer a flexible discount system. If you are located in another region and are looking to buy aprotinin in Kyiv or other cities, we organize prompt logistics while maintaining temperature control.

Applications

The raw material is used to manufacture drugs used in surgery, traumatology, and gastroenterology. When considering the question of what aprotinin helps with in clinical practice, the substance's main applications include:

Treatment of pancreatitis: Aprotinin's effectiveness in acute pancreatitis and pancreatic necrosis has been proven. It prevents enzymatic autolysis (self-digestion) of the pancreas. Therefore, aprotinin for pancreatitis remains an important component of combination therapy.

Surgery and hemostasis: It is used to prevent intraoperative blood loss, especially during open heart surgery and coronary artery bypass grafting.

Laboratory diagnostics: It is used as an inhibitor in "protease inhibitor cocktails" to protect proteins during cell lysis and purification.

Shock conditions: As part of combination therapy for traumatic and hemorrhagic shock.

Storage conditions and safety

The product is sensitive to environmental conditions.Aprotinin instructions for use for the substance prescribe storage in a place protected from light at a temperature of +2°C to +8°C. The reconstituted solution may be stored at low temperatures (down to -20°C).

According to the Certificate of Analysis, the substance passed the abnormal toxicity test and was found to be non-toxic at a concentration of 2 Ph.Eur.U./ml. The pyrogenicity and bacterial endotoxin tests also demonstrate compliance with standards for parenteral use.

Aprotinin indications for use and dosages listed in this product card relate to the properties of the active substance and are intended for technologists and pharmacists. For a commercial offer, please contact our sales department.

Price upon request

Features

CAS No.	9087-70-1
Solubility	Soluble in water and 0.9% NaCl solution, practically insoluble in organic solvents
Chemical formula	C284H432N84O79S7
English name	Aprotinin
Molecular weight	~ 6512 Yes
Appearance	Powder of almost white color, hygroscopic
Packaging	Standard (sealed)
HS code (customs code)	3504.00
Certification	Complies with EP 11.0
Specification (key indicators)	3.0 Ph.Eur.U./mg
Melting point	> 100 °C
Losses during drying	4.5% (with the norm > 6.0%)
pH	5.8 (with the norm being 5.5–7.0)
Storage conditions	"Passes the test"
Safety / Toxicology	Non-toxic (test at 2 Ph.Eur.U./ml)

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Characteristics Table

Aprotinin Specifications and Analysis Results

Detailed description and advantages

Applications

Storage conditions and safety

Delivery

Payment

Characteristic	Value / Description
Product Name	Aprotinin
English Name	Aprotinin
Chemical Formula	C284H432N84O79S7
CAS Number	9087-70-1
Molecular Weight	~ 6512 Da
Appearance	Almost white powder, hygroscopic
Packaging	Standard (hermetic)
EC (EINECS) Number	232-994-9
HS Code (Customs Code)	3504.00
Country of Origin	On Request
Certification	Complies with EP 11.0
Specification	3.0 Ph.Eur.U./mg
Activity (Actual)	3.40 EPU/mg (6113 KIU/mg)
Melting point	> 100 °C
Losses on drying	4.5% (at standard >6.0%)
Aprotinin oligomers	0.27% (at standard Max. 1.0%)
Impurities (Des-Ala-aprotinin)	7.6% (at standard >8.0%)
Impurities (Des-Ala-des-Gly)	7.0% (at standard > 7.5%)
pH (1% solution)	5.8 (normal 5.5–7.0)
Solubility	Soluble in water and 0.9% NaCl solution, practically insoluble in organic solvents
Solution appearance	Transparent (15 Ph.Eur.U./ml)
Endotoxins	>0.14 EU/ Ph.Eur.U. (Complies)
Storage Conditions	+2°C to +8°C
Safety and Toxicity	Non-toxic (test at 2 Ph.Eur.U./ml)

Quality Index	Specification (Requirements)	Analysis Result	Compliance standard
Activity	≥ 3.0 Ph.Eur.U./mg	3.40 Ph.Eur.U./mg (6113 KIU/mg)	Complies
Appearance	Almost white powder, hygroscopic	Complies	Complies
Solution appearance	Transparent (15 Ph.Eur.U./ml)	Complies	Complies
Identification A	Positive	Conforms	Conforms
Identification B	Positive	Conforms	Conforms
pH	5.5 – 7.0	5.8	Complies
Absorbance	A≤0.80 (max. absorbance: 277 nm±2 nm; 3.0 Ph.Eur.U./ml)	0.71	Complies
Aprotinin oligomers	Max. 1.0%	0.27%	Complies
Des-Ala-aprotinin and Des-Ala-des-Gly-aprotinin	Impurity A: <8.0%; Impurity B: <7.5%	Impurity A: 7.6%; Impurity B: 7.0%	Complies
Pyroglutamyl-aprotinin and related compounds	Pyroglutamyl-aprotinin: max. 1.0%; Any other impurity: max. 0.5%; Total impurities (except pyroglutamyl-aprotinin): max. 1.0%	Pyroglutamyl-aprotinin: 0.58%; Any other impurity: 0.16%, 0.24%, 0.35%; Total impurities: 0.75%	Complies
Loss on drying	≤ 6.0% (0.100 g, vacuum dried)	4.5%	Complies
Solubility	Soluble in water and 0.9% NaCl solution, practically insoluble in organic solvents (5 mg/ml)	Complies	Complies
Endotoxins	≤ 0.14 EU/Ph.Eur.U.	Complies	Complies
Pyrogens	Absent at 15 Ph.Eur.U./kg (rabbit)	Complies	Complies
Microbiological purity	TAMC: <10 2 CFU/g; TYMC: <10 2 CFU/g; Enterobacteriaceae, Pseudomonas aeruginosa, Staphylococcus aureus: Absence	Complies	Complies
Abnormal toxicity	Non-toxic at 2 Ph.Eur.U./ml	Complies	Complies
Histamine	0.1 μg histamine base / 3 Ph.Eur.U.	Complies	Complies

	Quantity	Out of stock

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