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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
Sofosbuvir Impurity 8 Sofosbuvir Impurity 8 944476-44-2 C24H22N2O8
135270-13-2 135270-13-2 135270-13-2 C12H11F2N3O
1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid 1-((2'-cyanobiphenyl-4-yl)methyl)-4-methyl-2-propyl-1H-benzo[d]imidazole-6-carboxylic acid 1098100-87-8 C26H23N3O2
Fimasartan Impurity Fimasartan Impurity
2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid 2-(((5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methyl)(methyl)amino)succinic acid C21H20FN3O6S
()-Olivil 4″-O-glucoside ()-Olivil 4″-O-glucoside 76880-93-8 C26H34O12
2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE 2-(DIETHYLAMINO)-N-(2,4-DIMETHYLPHENYL)ACETAMIDE 17289-53-1 C14H22N2O
4-[4-(diMethylaMino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxyMethyl)-benzonitrile (CitalopraM Olefinic IMpurity) 4-[4-(diMethylaMino)-1-(4-fluorophenyl)-1-buten-1-yl]-3-(hydroxyMethyl)-benzonitrile (CitalopraM Olefinic IMpurity) 920282-75-3 C20H21FN2O
Isatin indicator solution Isatin indicator solution C8H5NO2
Oxaliplatin impurity Oxaliplatin impurity
NiMesulide EP IMpurity NiMesulide EP IMpurity 38880-53-4 C7H8N2O5S
Alogliptin Impurity D Alogliptin Impurity D 1926163-25-8 C61H86N16O13
Moxifloxacin Impurities Moxifloxacin Impurities
Parecoxib Impurity K Parecoxib Impurity K 198471-69-1 C17H16N2O3S
Linagliptin Impurity K Linagliptin Impurity K 1638744-06-5 C25H29BrN8O2
(R)-2-((6-(3-((3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile (R)-2-((6-(3-((3-(2-cyano-5-fluorobenzyl)-1-methyl-2,6-dioxo-1,2,3,6-tetrahydropyrimidin-4-yl)amino)piperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)methyl)-4-fluorobenzonitrile 1917324-13-0 C31H28F2N8O4
L-Phenylalanine, N-[(5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl]-3-(methylsulfonyl)-, phenylmethyl ester, hydrochloride (1:1) L-Phenylalanine, N-[(5,7-dichloro-1,2,3,4-tetrahydro-6-isoquinolinyl)carbonyl]-3-(methylsulfonyl)-, phenylmethyl ester, hydrochloride (1:1) 1194550-65-6 C27H27Cl3N2O5S
Alogliptin Related Compound 23 Alogliptin Related Compound 23 1618644-29-3 C20H13ClN4O2
Etoricoxib Impurity 14 Etoricoxib Impurity 14
Riociguat Impurtiy 3 Riociguat Impurtiy 3
Trelagliptin Impurity 2 Trelagliptin Impurity 2
Chlorhexidine Impurity B Chlorhexidine Impurity B 1308292-89-8 C16H26ClN9O
Dapoxetine Impurity D Dapoxetine Impurity D
Eltrombopag Impurity 5 Eltrombopag Impurity 5
Exemestane Impurity 1 Exemestane Impurity 1 159354-61-7 C20H24O3
Iguratimod Impurity 9 Iguratimod Impurity 9 1179354-65-4 C18H16N2O6S
Lidocaine Impurity Lidocaine Impurity 35891-84-0 C11H16N2O.ClH
Pramipexole Impurity J Pramipexole Impurity J
Rosuvastatin EP Impurity B (Sodium Salt) Rosuvastatin EP Impurity B (Sodium Salt)
Solifenacin Related Compound 14 Solifenacin Related Compound 14 605696-10-4 C25H30N2O2
4-amino-1-((2R,3R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 4-amino-1-((2R,3R,5S)-2-(hydroxymethyl)-3-oxido-1,3-oxathiolan-5-yl)pyrimidin-2(1H)-one 160552-54-5 C8H11N3O4S
1-(4-Hydroxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide 1-(4-Hydroxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide 503612-76-8 C24H23N5O4
8-[(1R)-1-Hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]amino]ethyl]-6-(phenylmethoxy)-2H-1,4-benzoxazin-3(4H)-one 8-[(1R)-1-Hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]amino]ethyl]-6-(phenylmethoxy)-2H-1,4-benzoxazin-3(4H)-one 869478-13-7 C28H32N2O5
1-(2-(methylamino)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 1-(2-(methylamino)ethyl)piperidin-4-yl [1,1'-biphenyl]-2-ylcarbamate 743460-48-2 C21H27N3O2
Cefuroxime Sodium impurity D Cefuroxime Sodium impurity D C16H16N4NaO8S
Silodosin impurity A Silodosin impurity A
cefditoren △-3 isomer cefditoren △-3 isomer
Ixazomib Impurity 1 Ixazomib Impurity 1 1201903-02-7 C24H33BCl2N2O4
Ofloxacin/Levofloxacin Impurity E Ofloxacin/Levofloxacin Impurity E
(3S)-9,10-difluoro-3-methyl-7-oxo-2,3,6,7-tetrahydro-5H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid (3S)-9,10-difluoro-3-methyl-7-oxo-2,3,6,7-tetrahydro-5H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid 1026952-91-9 C13H11F2NO4
((4-Methoxyphenoxy)methylene)dibenzene ((4-Methoxyphenoxy)methylene)dibenzene 85686-16-4 C20H18O2
Tofacitinib Impurity L Tofacitinib Impurity L
1-chloro-3-(dimethoxymethyl)benzene 1-chloro-3-(dimethoxymethyl)benzene 3395-80-0 C9H11ClO2
N-(3-bromo-4-oxocyclohexyl)acetamide N-(3-bromo-4-oxocyclohexyl)acetamide 687639-03-8 C8H12BrNO2
methyl (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate methyl (Z)-3-(hydroxy(phenyl)methylene)-2-oxoindoline-6-carboxylate C44H51N9O4
Alvimopan Impurity 5 Alvimopan Impurity 5
Palbociclib-d8 Palbociclib-d8 1628752-83-9 C24H21D8N7O2
Ivabradine Impurity 15 Ivabradine Impurity 15 1132667-04-9 C12H17NO2
Sofosbuvir Impurity27 Sofosbuvir Impurity27
Isavuconazole Impurity 12 Isavuconazole Impurity 12
Tacrolimus Impurity 3 Tacrolimus Impurity 3 161861-10-5 C45H71NO13
Aprepitant EP Impurity C Aprepitant EP Impurity C 2208275-99-2 C29H25F7N4O3
Bisoprolol EP Impurity J Bisoprolol EP Impurity J 1797024-50-0 C15H24O5
Ceftriaxone Impurity Ceftriaxone Impurity 79221-95-7 C18H18N8O8S3
1-(4-methoxyphenyl)-2-methylpropan-2-amine 1-(4-methoxyphenyl)-2-methylpropan-2-amine 56490-94-9 C11H17NO
product/153101 product/153101
2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine 2-Methyl-5,6-dihydro-4H-benzo[b]oxazolo[5,4-d]azepine 877858-27-0 C12H12N2O
Miconazole IMpurity H Miconazole IMpurity H 181931-30-6 C18H16Cl2N2O
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
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
Betaxolol EP Impurity E Betaxolol EP Impurity E 1329613-85-5 C18H31NO3
Tulobuterol Impurity Tulobuterol Impurity 34356-83-7 C8H5Br2ClO
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