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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
Apixaban IMpurity(BMS-778960-01) Apixaban IMpurity(BMS-778960-01)
1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose 1,3,5-Tri-O-benzoyl-2-deoxy-2-fluoro-α-D-ribofuranose 704916-12-1 C26H21FO7
Chlorpheniramine Chlorpheniramine 78539-96-5 C16H19ClN2
9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin 9-(2,5-d|Dioxo-L-3-aMino-1-pyrrolidineacetic acid)-10-deglycine DaptoMycin 121869-35-0 C72H99N17O25
(1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine (1S,2S,5S)-4-[2-[2-(6,6-DiMethylbicyclo[3.1.1]hept-2-yl)ethoxy]ethyl]Morpholine 38284-47-8 C17H31NO2
[4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone [4-(4-AMino-6-hydroxy-7-Methoxy-2-quinazolinyl)-1-piperazinyl](tetrahydro-2-furanyl)Methanone 105356-89-6 C18H23N5O4
2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester 2,2'-[4-(2-Methylpropoxy)-1,3-phenylene]bis[4-Methyl-5-thiazolecarboxylic Acid 5,5'-DiMethyl Ester 1330632-47-7 C22H24N2O5S2
2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride 2-(DiethylaMino)-N-(2,4-diMethylphenyl)acetaMide Hydrochloride 17289-54-2 C14H23ClN2O
3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine 3-(5-Methyl-1H-iMidazol-1-yl)-5-(trifluoroMethyl)benzenaMine 641571-16-6 C11H10F3N3
4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide 4-[[3-(4-Methylphenyl)-3-oxo-1-(trifluoroMethyl)propylidene]aMino]benzenesulfonaMide 1061214-09-2 C17H15F3N2O3S
5-(Ethoxycarbonyl)-2-(hydroxyMethyl-6-Methyl-4-(3-nitrophenyl)nicotinic Acid 5-(Ethoxycarbonyl)-2-(hydroxyMethyl-6-Methyl-4-(3-nitrophenyl)nicotinic Acid 89267-43-6 C17H16N2O7
9-L-β-Aspartic acid-daptoMycin 9-L-β-Aspartic acid-daptoMycin 123180-72-3 C72H101N17O26
Chlorhexidine Digluconate IMpurity K Chlorhexidine Digluconate IMpurity K 1381962-77-1 C22H29Cl2N9O
Cyclopropyl 3-Fluorobenzyl Ketone Cyclopropyl 3-Fluorobenzyl Ketone 952722-64-4 C11H11FO
Linear DaptoMycin Linear DaptoMycin 883991-21-7 C72H103N17O27
N,N-DiMethylaMidino) Urea N,N-DiMethylaMidino) Urea 98026-16-5 C4H10N4O
rac Dehydro-O-desMethyl Venlafaxine rac Dehydro-O-desMethyl Venlafaxine 1346600-38-1 C16H23NO
3-HYDROXY DESLORATADINE HCL 3-HYDROXY DESLORATADINE HCL 119410-08-1 C19H19ClN2O
(S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID (S)-4-(TERT-BUTOXY)-2-ISOPROPYL-4-OXOBUTANOIC ACID 134807-43-5 C11H20O4
Acarbose D-Fructose IMpurity Acarbose D-Fructose IMpurity 1013621-79-8 C25H43NO18
2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide 2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-aMino-9H-purin-9-yl)-1-Methylethoxy]Methyl]-, 1-ethyl 9-(1-Methylethyl) ester, 5-oxide 1422284-16-9 C18H28N5O10P
(R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol (R)-α-[2-(1-naphthalenyloxy)ethyl]-benzeneMethanol 156453-53-1 C19H18O2
2-Fluoro-α-(2-methyl-1-oxopropyl)-γ-oxo-N,β-diphenyl-benzenebutanamide 2-Fluoro-α-(2-methyl-1-oxopropyl)-γ-oxo-N,β-diphenyl-benzenebutanamide 1797905-42-0 C26H24FNO3
Atorvastatin Lactam Lactone Atorvastatin Lactam Lactone 1795791-15-9 C33H31FN2O5
Vinorelbine N'b-Oxide Sulfate Salt Vinorelbine N'b-Oxide Sulfate Salt 74075-34-6 C45H54N4O9
Linagliptin iMpurity G Linagliptin iMpurity G 668270-11-9 C25H28N8O2
Tadalafil EP IMpurity F Tadalafil EP IMpurity F
(2R,3R,4R,5S)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-fluoro-4-Methyltetrahydrofuran-3-yl benzoate (2R,3R,4R,5S)-5-(4-benzaMido-2-oxopyriMidin-1(2H)-yl)-2-((benzoyloxy)Methyl)-4-fluoro-4-Methyltetrahydrofuran-3-yl benzoate 874638-94-5 C31H26FN3O7
CefuroxiMe sodiuM iMpurity B CefuroxiMe sodiuM iMpurity B C16H16N4NaO8S
Fasudil N-hydroxy iMpurity Fasudil N-hydroxy iMpurity 1350827-92-7 C14H17N3O3S
TaMsulosin IMpurity A TaMsulosin IMpurity A C20H28N2O5S
1-((2'-cyanobiphenyl-4-yl)Methyl)-2-ethoxy-1H-benziMidazole-7-carboxylic acid 1-((2'-cyanobiphenyl-4-yl)Methyl)-2-ethoxy-1H-benziMidazole-7-carboxylic acid 632322-61-3 C24H19N3O3
2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl Acetate 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethyl Acetate 844639-07-2 C23H27N3O3S
4-O-DesMethyl 4-O-Ethyl TriMethopriM 4-O-DesMethyl 4-O-Ethyl TriMethopriM 78025-68-0 C15H20N4O3
1-[[(2E)-3-Phenyl-2-propen-1-yl]oxy]naphthalene 1-[[(2E)-3-Phenyl-2-propen-1-yl]oxy]naphthalene 1091626-77-5 C19H16O
α-[[[2-(4-Methoxyphenyl)-1-Methylethyl](phenylMethyl)aMino]Methyl]-3-nitro-4-(phenylMethoxy)benzeneMethanol α-[[[2-(4-Methoxyphenyl)-1-Methylethyl](phenylMethyl)aMino]Methyl]-3-nitro-4-(phenylMethoxy)benzeneMethanol 43229-67-0 C32H34N2O5
Indacaterol IMrity Indacaterol IMrity 1235445-80-3 C24H28N2O3
Topiroxostat IMpurity Topiroxostat IMpurity
Flurbiprofen Impurity 17 Flurbiprofen Impurity 17 1206101-29-2 C24H16F2
Azilsartan Impurity Azilsartan Impurity 1586011-04-2 C26H25N3O4
1,2-Bis(piperazin-1-yl)benzene 1,2-Bis(piperazin-1-yl)benzene 1446750-99-7 C14H22N4
7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid 7-Methoxy-4-oxo-1,4-dihydroquinoline-6-carboxylic acid 417721-34-7 C11H9NO4
Pemetrexed Pemetrexed
Venlafaxine Venlafaxine C17H27NO2
(S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide (S)-4,5-dichloro-N-((2-oxo-3-(4-(3-oxoMorpholino)phenyl)oxazolidin-5-yl)Methyl)thiophene-2-carboxaMide 1770812-37-7 C19H17Cl2N3O5S
2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]- 2-Propen-1-one, 1-[4-[4-aMino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyriMidin-1-yl]-1-piperidinyl]- 936563-92-7 C25H24N6O2
8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one 8-cyclopentyl-5-Methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)aMino)-6-vinylpyrido[2,3-d]pyriMidin-7(8H)-one C24H29N7O
D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester D-Alanine, N-[[P(R),2'R]-2'-deoxy-2'-fluoro-2'-Methyl-P-phenyl-5'-uridylyl]-, 1-Methylethyl ester 1496552-16-9 C22H29FN3O9P
D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester D-Phenylalanine, N-[(1,1-diMethylethoxy)carbonyl]-L-leucyl-, Methyl ester 15136-32-0 C21H32N2O5
4-Nitro-2-phenoxyphenol 4-Nitro-2-phenoxyphenol 70995-08-3 C12H9NO4
Sofosbuvir Impurity Sofosbuvir Impurity 1233335-82-4 C16H25FN3O9P
Ethyl 3,4-O-isopropylideneshikiMate Ethyl 3,4-O-isopropylideneshikiMate 136994-78-0 C12H18O5
4-Vinyl-piperidine-4-carboxylic acid ethyl ester 4-Vinyl-piperidine-4-carboxylic acid ethyl ester 1509910-91-1 C10H17NO2
(2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid (2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-aMino-2-Methylpentanoic acid 1039307-95-3 C18H21NO2
EMpagliflozin  iMpurity 16 EMpagliflozin iMpurity 16
((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester ((R)-2-biphenyl-4-yl-1-forMylethyl)carbaMic acid t-butyl ester 149709-58-0 C20H23NO3
1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol 1-(2,3-DiMethylphenyl)-1-(1H-iMidazol-4-yl)ethanol 86347-12-8 C13H16N2O
(R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (R)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 1612153-32-8 C20H20FNO4
(S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one (S)-3-((R)-5-(4-fluorophenyl)-5-hydroxypentanoyl)-4-phenyloxazolidin-2-one 528565-93-7 C20H20FNO4
Posaconazole iMpurity 3 Posaconazole iMpurity 3
(3RS)-3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one (3RS)-3-[(Dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one C16H20N2O
1,2,4-Triazolo(3,4-b)benzothiazole-5-methanol 1,2,4-Triazolo(3,4-b)benzothiazole-5-methanol 69243-49-8 C9H7N3OS
Benzoicacid, 2-sulfino- Benzoicacid, 2-sulfino- 13165-80-5 C7H6O4S
Benzenemethanamine, a-ethyl-N,N-dimethyl- Benzenemethanamine, a-ethyl-N,N-dimethyl- 3330-05-0 C11H17N
CIS-1,2-BIS(AMINOMETHYL)CYCLOBUTANE CIS-1,2-BIS(AMINOMETHYL)CYCLOBUTANE 15286-88-1 C6H14N2
O-DesmethylApixabanSulphateNa O-DesmethylApixabanSulphateNa 1118765-14-2 C24H23N5O7S
4-Chloro-2-fluoro-N-methylbenzamide 4-Chloro-2-fluoro-N-methylbenzamide 1343038-33-4 C8H7ClFNO
N-FORMYL-1-(2-AMINO-1-(4-METHOXYPHENYL)ETHYL)CYCLOHEXANOL N-FORMYL-1-(2-AMINO-1-(4-METHOXYPHENYL)ETHYL)CYCLOHEXANOL 272788-07-5 C16H23NO3
2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 2-(7-methoxy-3,4-dihydronaphthalen-1-yl)ethan-1-amine 1353100-18-1 C13H18ClNO
Acotiamide  Impurity Acotiamide Impurity 198470-83-6 C20H21N2NaO4S
Terbutaline  Impurity Terbutaline Impurity 52144-90-8 C26H29NO3
methyl (41S,12R,13aR)-13a-ethyl-12-
hydroxy-2,3,41,5,6,12,13,13aoctahydro-
1H-indolo[3,2,1-
de]pyrido[3,2,1-ij][1,5]naphthyridine-
12-carboxylate methyl (41S,12R,13aR)-13a-ethyl-12- hydroxy-2,3,41,5,6,12,13,13aoctahydro- 1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine- 12-carboxylate 83508-83-2 C21H26N2O3
ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate 473465-11-1 C18H18N2O3S
Ethylmethyl-carbamic chloride Ethylmethyl-carbamic chloride 42252-34-6 C4H8ClNO
N-(3-{[(4-methylphenyl)sulfonyl]amino}phenyl)acetamide N-(3-{[(4-methylphenyl)sulfonyl]amino}phenyl)acetamide 329941-39-1 C15H16N2O3S
Cisatracurium-20-methyl Dibenzenesulfonate Cisatracurium-20-methyl Dibenzenesulfonate 1193104-85-6 C60H79N2O15S+
[R-(R*,S*)]-(-)-N-(1-PHENYLETHYL)-1-AZABICYCLO[2.2.2]OCTAN-3-AMINE DIHYDROCHLORIDE [R-(R*,S*)]-(-)-N-(1-PHENYLETHYL)-1-AZABICYCLO[2.2.2]OCTAN-3-AMINE DIHYDROCHLORIDE 128311-06-8 C15H24Cl2N2
GURKHSYORGJETM-MGDILKBHSA-N GURKHSYORGJETM-MGDILKBHSA-N 1992961-26-8 C33H39ClN4O6
DVCUGHHGLKCBMT-QVDQXJPCSA-N DVCUGHHGLKCBMT-QVDQXJPCSA-N 1356353-76-8 C15H24N6O6
5,6-Dehydro-Tigecycline 5,6-Dehydro-Tigecycline 1633815-62-9 C29H37N5O8
2,3,5,6-tetradeuterio-4-[5-[4-(hydroxymethyl)phenyl]-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide 2,3,5,6-tetradeuterio-4-[5-[4-(hydroxymethyl)phenyl]-3-(trifluoromethyl)pyrazol-1-yl]benzenesulfonamide 1276524-56-1 C17H10D4F3N3O3S
1,1-diphenylpropan-1-ol 1,1-diphenylpropan-1-ol 5180-33-6 C15H16O
(1R,5S)-1-phenyl-3-oxabicyclo[3.1.0]hexan-2-one (1R,5S)-1-phenyl-3-oxabicyclo[3.1.0]hexan-2-one 96847-52-8 C11H10O2
(1R,1'R,2S,2'S)-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-Isoquinolinium Benzenesulfonate (1R,1'R,2S,2'S)-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methyl-Isoquinolinium Benzenesulfonate 96946-46-2 C59H77N2O15S+
(2R,3R,4R,5R)-2-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-3-yl acetate (2R,3R,4R,5R)-2-(4-amino-2-oxo-1,3,5-triazin-1(2H)-yl)-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-3-yl acetate C10H14N4O6
12-ethyl-8-methyl-9-oxo-7-propionyl-9,11-dihydroindolizino[1,2-b]quinolin-2-yl [1,4'-bipiperidine]-1'-carboxylate 12-ethyl-8-methyl-9-oxo-7-propionyl-9,11-dihydroindolizino[1,2-b]quinolin-2-yl [1,4'-bipiperidine]-1'-carboxylate 176515-52-9 C32H38N4O4
4-amino-5-chloro-N-(1-propylpiperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide 4-amino-5-chloro-N-(1-propylpiperidin-4-yl)-2,3-dihydrobenzofuran-7-carboxamide C17H24ClN3O2
Ceftazidime Impurity D Ceftazidime Impurity D
Ceftazidime Sulfoxide Impurity Ceftazidime Sulfoxide Impurity
Tofacitinib Impurity Y Tofacitinib Impurity Y
5-amino-6-chloro-2-(propylthio)pyrimidin-4-ol 5-amino-6-chloro-2-(propylthio)pyrimidin-4-ol C7H10ClN3OS
Labetalol EP impurity G Labetalol EP impurity G
2-(2-NITROPHENYL)ETHANAMINE 2-(2-NITROPHENYL)ETHANAMINE 33100-15-1 C8H10N2O2
Bendamustine Impurity 25 Bendamustine Impurity 25
Canagliflozin Impurity 25 Canagliflozin Impurity 25
Edoxaban Impurity 41 Edoxaban Impurity 41 1353893-25-0 C14H27N3O3
Istradefylline Impurity 5 Istradefylline Impurity 5
Milrinone Impurity 10 Milrinone Impurity 10
N-(2-Chloro-ethyl)-N'-(2,3-dichloro-phenyl)-ethane-1,2-diamine N-(2-Chloro-ethyl)-N'-(2,3-dichloro-phenyl)-ethane-1,2-diamine C10H13Cl3N2
Olanzapine Impurity 3 Olanzapine Impurity 3 C17H20N4S
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