0.9% Sodium Chloride Injection Solution, Viaflex® Container

Semaglutide API Product Description:
COA Available Product with NDC Code

Available in the US and Canada.

Semaglutide API is indicated for improving glycemic control in adults with type 2 diabetes mellitus, in conjunction with diet and exercise. The approved therapeutic doses are 0.5 mg and 1 mg. Type 2 diabetes is a chronic metabolic disorder characterized by high blood sugar, insulin resistance, and insufficient insulin production. The onset of this condition is linked to the inability of beta cells to respond to increased plasma glucose, predominantly caused by lifestyle factors such as overweight and obesity. The key feature of type 2 diabetes is insulin resistance, which reduces insulin’s effectiveness at normal concentrations. Insulin secretion is stimulated by incretins like glucagon-like peptide 1 (GLP-1), which also delays gastric emptying and induces satiety.

Mode of Action:
Semaglutide API enhances glucose control through various mechanisms, including increased insulin secretion, slower gastric emptying, and reduced postprandial glucagon and food intake. The drug mimics the activity of GLP-1, a key hormone in glucose management, thanks to structural modifications that improve its stability against degradation by enzymes like dipeptidyl peptidase-4 (DPP-4). These modifications also promote specific binding to plasma albumin and prevent incorrect binding of fatty acids, resulting in an extended half-life and improved patient compliance.

Pharmacodynamics:
Clinical trials show that semaglutide significantly reduces glycated hemoglobin (HbA1c) compared to other medications, including sitagliptin, exenatide, and insulin glargine U100. HbA1c is a standard measure of high glucose levels, reflecting long-term blood sugar control. Additionally, semaglutide has been shown to reduce body weight, lower fasting and postprandial glucose levels, and decrease fasting triglycerides and VLDL cholesterol.

Metabolism:
Semaglutide is slowly but extensively metabolized before excretion, with 83% of the administered dose found unchanged in plasma. Six different metabolites have been identified, with the major metabolite accounting for 7.7% of the dose. The drug is primarily degraded by enzymes such as DPP-4 and neural endopeptidase (NEP), which inactivate semaglutide and hydrolyze its peptide bonds.

Toxicity:
In preclinical studies, mild c-cell hyperplasia and other effects, including liver necrosis and centrilobular hypertrophy, were observed at doses significantly higher than those used clinically. High doses also resulted in ECG abnormalities and tissue vacuolation.

IUPAC:
17-{[(1R)-3-[(2-{2-[({2-[2-({[(5S)-5-[(2S)-2-[(2S)-2-[(2S)-2-{2-[(2S)-2-[(2S)-2-[(2S)-2-[(2S)-2-[(2S)-2-[(2S)-2-[(2S)-2-[(2S)-2-[(2S,3R)-2-[(2S)-2-[(2S,3R)-2-{2-[(2S)-2-{2-[(2S)-2-amino-3-(1H-imidazol-4-yl)propanamido]-2-methylpropanamido}-4-carboxybutanamido]acetamido}-3-hydroxybutanamido]-3-phenylpropanamido]-3-hydroxybutanamido]-3-hydroxypropanamido]-3-carboxypropanamido]-3-methylbutanamido]-3-hydroxypropanamido]-3-hydroxypropanamido]-3-(4-hydroxyphenyl)propanamido]-4-methylpentanamido]-4-carboxybutanamido]acetamido}-4-carbamoylbutanamido]propanamido]propanamido]-5-{[(1S)-1-{[(1S)-1-{[(1S,2S)-1-{[(1S)-1-{[(1S)-1-{[(1S)-1-{[(1S)-1-{[(1S)-4-carbamimidamido-1-[({[(1S)-4-carbamimidamido-1-[(carboxymethyl)carbamoyl]butyl]carbamoyl}methyl)carbamoyl]butyl]carbamoyl}-2-methylpropyl]carbamoyl}-3-methylbutyl]carbamoyl}-2-(1H-indol-3-yl)ethyl]carbamoyl}ethyl]carbamoyl}-2-methylbutyl]carbamoyl}-2-phenylethyl]carbamoyl}-3-carboxypropyl]carbamoyl}pentyl]carbamoyl}methoxy)ethoxy]ethyl}carbamoyl)methoxy]ethoxy}ethyl)carbamoyl]-1-carboxypropyl]carbamoyl}heptadecanoic acid

DrugBank:
DB13928

Formula:
C187-H291-N45-O59

Molecular Mass:
Average: 4113.641
Monoisotopic: 4111.11537713

Synonyms:
Semaglutide / Semaglutide API
SMILES:
CC[C@H](C)[C@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(O)=O)C(O)=O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)C(C)(C)NC(=O)[C@@H](N)CC1=CNC=N1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(O)=O
InChi:
InChI=1S/C187H291N45O59/c1-18-105(10)154(180(282)208-108(13)159(261)216-133(86-114-89-200-119-50-40-39-49-117(114)119)170(272)218-129(82-102(4)5)171(273)228-152(103(6)7)178(280)215-121(53-44-72-199-186(192)193)162(264)201-91-141(242)209-120(52-43-71-198-185(190)191)161(263)204-94-151(257)258)230-172(274)131(83-111-45-33-31-34-46-111)219-167(269)126(64-69-149(253)254)214-166(268)122(51-41-42-70-195-144(245)98-290-79-78-289-76-74-197-145(246)99-291-80-77-288-75-73-196-139(240)66-61-127(183(285)286)211-140(241)54-37-29-27-25-23-21-19-20-22-24-26-28-30-38-55-146(247)248)212-158(260)107(12)206-157(259)106(11)207-165(267)125(60-65-138(189)239)210-142(243)92-202-163(265)123(62-67-147(249)250)213-168(270)128(81-101(2)3)217-169(271)130(85-113-56-58-116(238)59-57-113)220-175(277)135(95-233)223-177(279)137(97-235)224-179(281)153(104(8)9)229-174(276)134(88-150(255)256)221-176(278)136(96-234)225-182(284)156(110(15)237)231-173(275)132(84-112-47-35-32-36-48-112)222-181(283)155(109(14)236)227-143(244)93-203-164(266)124(63-68-148(251)252)226-184(287)187(16,17)232-160(262)118(188)87-115-90-194-100-205-115/h31-36,39-40,45-50,56-59,89-90,100-110,118,120-137,152-156,200,233-238H,18-30,37-38,41-44,51-55,60-88,91-99,188H2,1-17H3,(H2,189,239)(H,194,205)(H,195,245)(H,196,240)(H,197,246)(H,201,264)(H,202,265)(H,203,266)(H,204,263)(H,206,259)(H,207,267)(H,208,282)(H,209,242)(H,210,243)(H,211,241)(H,212,260)(H,213,270)(H,214,268)(H,215,280)(H,216,261)(H,217,271)(H,218,272)(H,219,269)(H,220,277)(H,221,278)(H,222,283)(H,223,279)(H,224,281)(H,225,284)(H,226,287)(H,227,244)(H,228,273)(H,229,276)(H,230,274)(H,231,275)(H,232,262)(H,247,248)(H,249,250)(H,251,252)(H,253,254)(H,255,256)(H,257,258)(H,285,286)(H4,190,191,198)(H4,192,193,199)/t105-,106-,107-,108-,109+,110+,118-,120-,121-,122-,123-,124-,125-,126-,127+,128-,129-,130-,131-,132-,133-,134-,135-,136-,137-,152-,153-,154-,155-,156-/m0/s1

Purchase of this product is restricted to licensed companies and labs.

Baxter Sterile Water for Irrigation, USP is a high-quality, sterile, nonpyrogenic solution designed to meet the needs of medical professionals. Each 1000ml container is carefully prepared to guarantee the absence of any bacteriostatic, antimicrobial agents, or other substances, resulting in a pure and dependable irrigation solution.

This sterile water is not isotonic and has hemolytic properties, making it an ideal choice for a variety of irrigation procedures where these specific characteristics are required. Trust Baxter for consistent, safe, and effective solutions in your medical practice.

Medicom® Safe-Seal® Quattro Self-Sealing Sterilization Pouches feature the state-of-the-art TruePress™ technology which ensures seal integrity. Extra-wide self-adhesive strip creates an airtight seal. High-quality, porous medical-grade paper maximizes steam penetration. The internal and external multivariable process indicators for steam sterilization respond to time, temperature, and saturated steam and are printed on the pouch for clear results. The tinted film allows easy detection of damage to the pouch. The thumb notch allows easy opening without contaminating sterile contents.

All Medicom sterilization pouches are validated to respond to 3 variables: time, temperature and steam/EO, and are compliant with the following Standards and Recommendations:

• CDC guidelines for Infection control
• AAMI ST-79 Standards, sections pertaining to external and internal chemical indicators
• ISO 11607 Standards for packaging of sterilized medical devices
• ISO 11140-1 & Standards for internal multi-variable chemical indicators and external process indicators

SafeSeal Quattro pouches give the user the assurance of confirming sterilization parameters in one easy step: time, temperature & steam/EO with internal & external multi-variable process indicators printed directly on the pouch. All Medicom pouches provide peace of mind, convenience and economy. Properly stored, they maintain the sterility of the instruments for up to 1 year post-sterilization. Finally, SafeSeal Quattro pouches are tested and certified by an independent laboratory.

SafeSeal Quattro Process Indicators:

• Now with a Class 4 internal multi-variable steam indicator and a Class 1 external process indicator for steam sterilization
• Respond to 3 variables: time, temperature and saturated steam
• Stated value of 2 minutes @134ºC in the presence of steam
• Class 1 internal and external process indicators for EO sterilization

Feature / Property: One-way valve, Economy Model