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Standard

In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.

According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.

In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.

International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.

Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.

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Structure Chemical Name CAS MF
BendaMustine IMpurity D BendaMustine N-Alkylated IMpurity BendaMustine IMpurity D BendaMustine N-Alkylated IMpurity
Cefradine IMpurity E Cefradine IMpurity E
Cetirizine IMpurity-7 Cetirizine IMpurity-7 C21H25ClN2O3
Dasatinib IMpurity 6 Dasatinib IMpurity 6
Desacetyl CefathiaMidine Desacetyl CefathiaMidine 958001-61-1 C17H26N4O5S2
Fluconazole IMpurity D Fluconazole IMpurity D C13H12F2N6O
Lercanidipine IMpurity A Lercanidipine IMpurity A 74936-74-6 C19H22N2O6
Loratadine 2-Chloro IMpurity Loratadine 2-Chloro IMpurity 165739-64-0 C22H22Cl2N2O2
Metoprolol IMpurity F Metoprolol IMpurity F C15H25NO3
Miconazole IMpurity I Miconazole IMpurity I 47363-37-1 C18H15Cl3N2O
Milrinone IMpurity 1 Milrinone IMpurity 1
Nicardipine Related CoMpound 2 Nicardipine Related CoMpound 2 64603-72-1 C16H14N2O6
Saxagliptin IMpurity 1 Saxagliptin IMpurity 1 1564266-73-4 C6H10N2O
Sitagliptin DeaMino IMpurity 1 Sitagliptin DeaMino IMpurity 1 1253056-18-6 C16H12F6N4O
Sitagliptin Defuoro IMpurity 5 Sitagliptin Defuoro IMpurity 5 486460-31-5 C16H16F5N5O
TiMolol IMpurity E TiMolol IMpurity E 1026075-53-5 C17H26N4O6S
EthanediaMide  iMpurity J EthanediaMide iMpurity J C2H4N2O2
4,6-dichloro-2-(propylthio)pyriMidine 4,6-dichloro-2-(propylthio)pyriMidine 1401318-10-2 C7H8Cl2N2S
Pramipexole EP Impurity E Pramipexole EP Impurity E 106006-84-2 C10H15N3OS
3-Morpholinone, 4-phenyl- 3-Morpholinone, 4-phenyl- 29518-11-4 C10H11NO2
H 128/80 H 128/80 29122-74-5 C13H19NO3
4’-Hydroxy Atomoxetine -D-Glucuronide 4’-Hydroxy Atomoxetine -D-Glucuronide 540729-08-6 C23H29NO8
Decarboxy Ciprofloxacin Decarboxy Ciprofloxacin 105394-83-0 C16H18FN3O
Zolpidem 6-Carboxylic Acid Zolpidem 6-Carboxylic Acid 109461-15-6 C19H19N3O3
Telmisartan tert-Butyl Ester Telmisartan tert-Butyl Ester 144702-26-1 C37H38N4O2
Amido Ethyl Meloxicam (Meloxicam Impurity) Amido Ethyl Meloxicam (Meloxicam Impurity) 881399-30-0 C16H17N3O4S2
Myricetin 3-β-D-glucopyranoside Myricetin 3-β-D-glucopyranoside 19833-12-6 C21H20O13
4-((2S,4S)-4-butoxy-1-((5-methoxy-7-methyl-1H-indol-4-yl)methyl)piperidin-2-yl)benzoic acid 4-((2S,4S)-4-butoxy-1-((5-methoxy-7-methyl-1H-indol-4-yl)methyl)piperidin-2-yl)benzoic acid
(2R,3S)-2-(4-(N-cyclopentyl-2-fluoro-6-methylbenzamido)phenyl)-1-(2-fluoro-6-methylbenzoyl)-N-(4-methyl-3-(trifluoromethyl)phenyl)piperidine-3-carboxamide (2R,3S)-2-(4-(N-cyclopentyl-2-fluoro-6-methylbenzamido)phenyl)-1-(2-fluoro-6-methylbenzoyl)-N-(4-methyl-3-(trifluoromethyl)phenyl)piperidine-3-carboxamide
2,4,5-Trifluoro-3-methoxybenzoyl chloride 2,4,5-Trifluoro-3-methoxybenzoyl chloride 112811-66-2 C8H4ClF3O2
1-(Dimethoxymethyl)-2-methoxybenzene 1-(Dimethoxymethyl)-2-methoxybenzene 58378-33-9 C10H14O3
2,3,5,4'-TETRAHYDROXYSTILBENE-2-O-BETA-D-GLUCOSIDE 2,3,5,4'-TETRAHYDROXYSTILBENE-2-O-BETA-D-GLUCOSIDE C20H22O9
N-(2-BENZOYL-4-CHLOROPHENYL)FORMAMIDE N-(2-BENZOYL-4-CHLOROPHENYL)FORMAMIDE 10352-28-0 C14H10ClNO2
Benzylpenicillin EP Impurity Benzylpenicillin EP Impurity 5985-13-7 C16H19N2NaO5S
4,4,4-TRIFLUORO-1-(3-METHYLPHENYL)-1,3-BUTANEDIONE 4,4,4-TRIFLUORO-1-(3-METHYLPHENYL)-1,3-BUTANEDIONE 53764-99-1 C11H9F3O2
DU 6856 DU 6856 127254-11-9 C19H18ClF2N3O3
N-(3-(6-amino-5-(2-(methyl(nitroso)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide N-(3-(6-amino-5-(2-(methyl(nitroso)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide 3103121-14-5 C24H24F2N6O3
N-Nitroso Aprocitentan N-Nitroso Aprocitentan
Sodium chloride standard titration solution c(NaCl)=0.1 mol/L Sodium chloride standard titration solution c(NaCl)=0.1 mol/L
Dexmedetomidine Impurity 4 Dexmedetomidine Impurity 4 1061620-86-7 C19H24N2O6
(3S,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid (3S,5R,6E)-7-[2-Cyclopropyl-4-(4-fluorophenyl)-3-quinolinyl]-3,5-dihydroxy-6-heptenoic acid 254452-86-3 C25H24FNO4
Favipravir Impurity 10 Favipravir Impurity 10
(E)-4-Acetoxy Tamoxifen (E)-4-Acetoxy Tamoxifen 76117-70-9 C28H31NO3
Atorvastatin Cyclic Isopropyl Impurity Atorvastatin Cyclic Isopropyl Impurity 873950-17-5 C33H35FN2O7
O-Acetyl Losartan O-Acetyl Losartan 1006062-27-6 C24H25ClN6O2
(2-Chloro-5-iodophenyl)(4-ethoxyphenyl)methanone (2-Chloro-5-iodophenyl)(4-ethoxyphenyl)methanone 1103738-26-6 C15H12ClIO2
3-Dechloro-4-chloro Lamotrigine 3-Dechloro-4-chloro Lamotrigine 38943-76-9 C9H7Cl2N5
D-2’-Deoxyribofuranosyl-3-guanylurea
(α/β-Mixture)
D-2’-Deoxyribofuranosyl-3-guanylurea (α/β-Mixture) 570410-72-9 C7H14N4O4
Difluoro Atorvastatin Difluoro Atorvastatin 693794-20-6 C66H66CaF4N4O10
(4S,trans)-1,1-Dimethylethyl-6-aminoethyl-2,2-dimethyl-1,3-dioxane-4-acetate (4S,trans)-1,1-Dimethylethyl-6-aminoethyl-2,2-dimethyl-1,3-dioxane-4-acetate 1105067-89-7 C14H27NO4
rac 5-Keto Fluvastatin rac 5-Keto Fluvastatin 1160169-39-0 C24H24FNO4
9-Piperazino Ofloxacin 9-Piperazino Ofloxacin 197291-75-1 C18H20FN3O4
Istradefylline impurity B Istradefylline impurity B
Ticagrelor diastereoMer Ticagrelor diastereoMer 1459719-81-3 C9H9F2N
Nsc249004 Nsc249004 7428-39-9 C9H13N3O5
Thyroxine-4-hydroxy-3,5-diiodophenyl Ether DISCONTINUED Thyroxine-4-hydroxy-3,5-diiodophenyl Ether DISCONTINUED 911661-90-0 C21H13I6NO5
(S)-Ethyl 2-((3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl)pentanoate ,95% (S)-Ethyl 2-((3S,5aS,9aS,10aS)-3-methyl-1,4-dioxodecahydropyrazino[1,2-a]indol-2(1H)-yl)pentanoate ,95% 129970-98-5 C19H30N2O4
Exemestane Impurity A Exemestane Impurity A
(1R,3S)-1-(1,3-Benzodioxol-5-yl)-2-(2-chloroacetyl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester (1R,3S)-1-(1,3-Benzodioxol-5-yl)-2-(2-chloroacetyl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylic Acid Methyl Ester 629652-44-4 C22H19ClN2O5
3-DesMorpholinyl-3-hydroxyethylaMino Gefitinib 3-DesMorpholinyl-3-hydroxyethylaMino Gefitinib 847949-56-8 C20H22ClFN4O3
4-Deschloro-4-(2-furanylMethyl)aMino FuroseMide 4-Deschloro-4-(2-furanylMethyl)aMino FuroseMide 5046-19-5 C17H17N3O6S
Cephalexin Sulfoxide Cephalexin Sulfoxide 56193-21-6 C16H17N3O5S
N-Butyl Nor ScopolaMine Hydrochloride N-Butyl Nor ScopolaMine Hydrochloride 22235-98-9 C20H28ClNO4
11β-Hydroxy Dienogest 11β-Hydroxy Dienogest 86153-39-1 C20H25NO3
2H,5H-Pyrano[4,3-b]pyranyl Mupirocin SodiuM IMpurity 2H,5H-Pyrano[4,3-b]pyranyl Mupirocin SodiuM IMpurity 116182-44-6 C26H43NaO9
3-Hydroxy CitalopraM 3-Hydroxy CitalopraM 411221-53-9 C20H21FN2O2
5-(OxiranylMethoxy)-2,3,4,9-tetrahydrocarbazole 5-(OxiranylMethoxy)-2,3,4,9-tetrahydrocarbazole 58457-32-2 C15H17NO2
6α-Methyl Hydrocortisone 21-HeMisuccinate 6α-Methyl Hydrocortisone 21-HeMisuccinate 119657-85-1 C26H36O8
Hydroxy TorseMide Hydroxy TorseMide 99300-68-2 C16H20N4O4S
Hydroxy Varenicline N-Trifluoroacetate Hydroxy Varenicline N-Trifluoroacetate 357426-10-9 C15H12F3N3O2
N2-Methyl Alfuzosin Hydrochloride N2-Methyl Alfuzosin Hydrochloride 72104-34-8 C19H28ClN5O4
N2-Methyl Alfuzosin Hydrochloride N2-Methyl Alfuzosin Hydrochloride 72104-34-8 C19H28ClN5O4
N-ForMyl Valacyclovir N-ForMyl Valacyclovir 847670-62-6 C14H20N6O5
2-Fluorobiphenyl-4-carboxylic Acid 2-Fluorobiphenyl-4-carboxylic Acid 137045-30-8 C13H9FO2
Theophyllidine Hydrochloride Theophyllidine Hydrochloride 116131-08-9 C6H10ClN4O
1,4'-Dimethyl-2'-propyl-2,5'-bi-1H-benzimidazole 1,4'-Dimethyl-2'-propyl-2,5'-bi-1H-benzimidazole 887583-89-3 C19H20N4
Tetracyclics compound impurities Tetracyclics compound impurities
Urapidil Impurity Urapidil Impurity 770-42-3 C8H9BrFN.BrH
N'-(1-Methylazepan-4-yl)benzohydrazine N'-(1-Methylazepan-4-yl)benzohydrazine 117078-69-0 C14H22ClN3O
3-(3-Chloropropyl)-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one 3-(3-Chloropropyl)-7,8-dimethoxy-2,3,4,5-tetrahydro-1H-3-benzazepin-2-one 85175-65-1 C15H20ClNO3
N-DesMethyl TelMisartan N-DesMethyl TelMisartan 144701-81-5 C32H28N4O2
N-De[2-(Methylsulfonyl)ethyl] Lapatinib N-De[2-(Methylsulfonyl)ethyl] Lapatinib 697299-82-4 C26H20ClFN4O2
N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole Sulfide N-[(3,4-DiMethoxy-2-pyridinyl)Methyl] Pantoprazole Sulfide 957470-58-5 C24H24F2N4O5S
3-Oxo Rosuvastatin SodiuM Salt 3-Oxo Rosuvastatin SodiuM Salt 1346606-28-7 C22H25FN3NaO6S
Famciclovir Related Compound A (20 mg) (2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol hydrochloride) Famciclovir Related Compound A (20 mg) (2-[2-(2-Amino-9H-purin-9-yl)ethyl]propane-1,3-diol hydrochloride) 246021-75-0 C10H16ClN5O2
Olopatadine USP RC B Olopatadine USP RC B 173174-07-7 C21H23NO4
Ramipril Related Compound A (30 mg) ((2S,3aS,6aS)-1-[(S)2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic acid) Ramipril Related Compound A (30 mg) ((2S,3aS,6aS)-1-[(S)2-[[(S)-1-(methoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-octahydrocyclopenta[b]pyrrole-2-carboxylic acid) 108313-11-7 C22H30N2O5
1-(2,3-EPOXYPROPYL)-2-METHYL-5-NITROIMIDAZOLE 1-(2,3-EPOXYPROPYL)-2-METHYL-5-NITROIMIDAZOLE 16773-52-7 C7H9N3O3
Bendamustine Related Impurity 12 Bendamustine Related Impurity 12
Bendamustine Related Impurity 3 Bendamustine Related Impurity 3
Edoxaban Impurity 26 (1R,2S,4R) Edoxaban Impurity 26 (1R,2S,4R) 1255529-33-9 C21H30ClN5O5
Ezetimibe Impurity 36 Ezetimibe Impurity 36 1809031-15-9 C39H46F2N2O5Si2
Linagliptin Impurity 29 Linagliptin Impurity 29 2074688-82-5 C58H58N16O6
Methylprednisolone Acetate EP Impurity H Methylprednisolone Acetate EP Impurity H 1968-76-9 C24H32O4
Rivaroxaban Impurity 44 Rivaroxaban Impurity 44
Sitafloxacin Impurity 3 Sitafloxacin Impurity 3 C23H10Cl2F4N2O6
Tenofovir Impurity 39 Tenofovir Impurity 39
Ticagrelor Related Compound 82 Ticagrelor Related Compound 82
Vonoprazan Impurity 20 Vonoprazan Impurity 20
N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(4-methoxyphenoxy)propyl]-1-piperazineacetamide N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(4-methoxyphenoxy)propyl]-1-piperazineacetamide 1393717-45-7 C24H33N3O4
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