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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
3-(3-TRIFLUOROMETHYL-PHENYL)-PROPYLAMINE 3-(3-TRIFLUOROMETHYL-PHENYL)-PROPYLAMINE 104774-87-0 C10H12F3N
4-(3,4-Dichloro-phenyl)-3,4-dihydro-2H-naphthalen-1-one 4-(3,4-Dichloro-phenyl)-3,4-dihydro-2H-naphthalen-1-one 124379-29-9 C16H12Cl2O
(4-(2-(azepan-1-yl)ethoxy)phenyl)Methanol (4-(2-(azepan-1-yl)ethoxy)phenyl)Methanol 223251-16-9 C15H23NO2
4-HYDROXY PROPOFOL 4-HYDROXY PROPOFOL 1988-10-9 C12H18O2
(2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic acid tert-butyl ester (2S,4S)-4-[4-(3-Methyl-1-phenyl-1H-pyrazol-5-yl)-1-piperazinyl]-2-(3-thiazolidinylcarbonyl)-1-pyrrolidinecarboxylic acid tert-butyl ester 401566-80-1 C27H38N6O3S
trans-4,5-Dichloro-4,5-diMethyl-1,3-dioxolan-2-one trans-4,5-Dichloro-4,5-diMethyl-1,3-dioxolan-2-one 116857-05-7 C5H6Cl2O3
4-Methoxy-5-(3-Morpholinopropoxy)-2-nitrobenzaMide 4-Methoxy-5-(3-Morpholinopropoxy)-2-nitrobenzaMide 861453-16-9 C15H21N3O6
5-chloro-3-sulfo-2-Thiophenecarboxylic acid 5-chloro-3-sulfo-2-Thiophenecarboxylic acid 187746-94-7 C5H3ClO5S2
2,2'-(4,4'-(3,3'-(isopropylazanediyl)bis(2-hydroxypropane-3,1-diyl))bis(oxy)bis(4,1-phenylene))diacetaMide 2,2'-(4,4'-(3,3'-(isopropylazanediyl)bis(2-hydroxypropane-3,1-diyl))bis(oxy)bis(4,1-phenylene))diacetaMide 87619-83-8 C25H35N3O6
5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid hydrochloride 5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid hydrochloride 720720-96-7 C8H11ClN2O2S
3,3'-diMethyl-1,1'-diphenyl-1H,1'H-4,4'-bipyrazole-5,5'-diol 3,3'-diMethyl-1,1'-diphenyl-1H,1'H-4,4'-bipyrazole-5,5'-diol 177415-76-8 C20H18N4O2
5-(2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 5-(2-cyclopropyl-1-(3-fluorophenyl)-2-oxoethyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 1391194-39-0 C20H20FNO3S
ApreMilast IMpurity ApreMilast IMpurity
5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 5'-broMo-[2,3'-bipyridin]-6'(1'H)-one 381233-79-0 C10H7BrN2O
(S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide (S)-N-(1-(3-MethylbutanaMido)-1-oxo-3-phenylpropan-2-yl)pyrazine-2-carboxaMide 862894-96-0 C19H22N4O3
Ticagrelor iMpurity Ticagrelor iMpurity 1882095-51-3 C27H45N5O8S
cefaclor iMpurity G cefaclor iMpurity G 67308-21-8 C16H17N3O4S
Rupatadine iMpurity E Rupatadine iMpurity E
Tadalafil iMpurity D Tadalafil iMpurity D 951661-81-7 C22H20ClN3O4
2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester 2-Thiopheneacetic acid, α-hydroxy-α-2-thienyl-, (3R)-1-azabicyclo[2.2.2]oct-3-yl ester 320347-97-5 C17H19NO3S2
benzbroMarone iMpurity benzbroMarone iMpurity
Dasatinib iMpurity Dasatinib iMpurity 1184919-23-0 C22H27N7O2S
eszopiclone iMpurity eszopiclone iMpurity
IMidafenacin iMpurity IMidafenacin iMpurity 503599-41-5 C18H20N2O2
latanoprost iMpurity latanoprost iMpurity 733036-95-8 C25H35FO5
Irbesartan IMpurity D Irbesartan IMpurity D C25H28N6O
Ondansetron HCl IMpurity-G Ondansetron HCl IMpurity-G 99614-03-6 C17H17N3O
lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate lithiuM 2-(4-(Methylsulfonyl)phenyl)acetate 1421227-96-4 C9H11LiO4S
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetaMide) 120512-03-0 C17H21N5O
AtracuriuM IMpurity I (Mixture of cis, trans(I1), cis, cis(I2), tans, trans IsoMer) AtracuriuM IMpurity I (Mixture of cis, trans(I1), cis, cis(I2), tans, trans IsoMer)
Ceftriaxone IMpurit C Ceftriaxone IMpurit C
Flucloxacillin IMpurity G Flucloxacillin IMpurity G
Gefitinib N-Oxide Gefitinib N-Oxide 847949-51-3 C22H24ClFN4O4
Milrinone IMpurity 3 Milrinone IMpurity 3 98293-81-3 C12H7N3O3
Nicardipine Related CoMpound 4 Nicardipine Related CoMpound 4 123973-71-7 C25H27N3O6
PraMipexole IMp.BI-II786BS PraMipexole IMp.BI-II786BS
Propofol IMpurity E Propofol IMpurity E
Solifenacin Related CoMpound 5 Solifenacin Related CoMpound 5
TelMisartan BroMo Ethyl Ester TelMisartan BroMo Ethyl Ester 133085-87-7 C16H15BrO2
Tolterodine Lactol IMpurity Tolterodine Lactol IMpurity 209747-04-6 C16H16O2
Valsartan N1-Trityl IMpurity Valsartan N1-Trityl IMpurity
(3-Carbamoylallyl)trimethylammonium (3-Carbamoylallyl)trimethylammonium 857162-57-3 C7H15N2O+
3-CHLORO-4-HYDROXYACETANILIDE 3-CHLORO-4-HYDROXYACETANILIDE 3964-54-3 C8H8ClNO2
Apixaban IMpurity(BMS-591329-01) Apixaban IMpurity(BMS-591329-01)
ent-14S-3-Methoxy-17-MethylMorphinan ent-14S-3-Methoxy-17-MethylMorphinan 1453167-99-1 C18H25NO
PD 224378 PD 224378 501665-88-9 C20H35NO11
(rac,syn)-4-Deschloro-sertraline (rac,syn)-4-Deschloro-sertraline 871838-58-3 C17H18ClN
1-[2-(DiMethylaMino)-1-phenylethyl]cyclohexanol 1-[2-(DiMethylaMino)-1-phenylethyl]cyclohexanol 93413-86-6 C16H25NO
1-[4-(2-Methoxyethenyl)phenoxy]-3-[(1-Methylethyl)aMino]-2-propanol 1-[4-(2-Methoxyethenyl)phenoxy]-3-[(1-Methylethyl)aMino]-2-propanol 82961-02-2 C15H23NO3
11-Desethyl Irinotecan 11-Desethyl Irinotecan 103816-16-6 C31H34N4O6
5-Methoxy-2-[[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]thio]-1H-benziMidazole N-Oxide 5-Methoxy-2-[[(4-Methoxy-3,5-diMethyl-2-pyridinyl)Methyl]thio]-1H-benziMidazole N-Oxide 142885-92-5 C17H19N3O3S
7-[[[(CyanoMethyl)thio]acetyl]aMino]-7-Methoxy Cephalosporanic Acid 7-[[[(CyanoMethyl)thio]acetyl]aMino]-7-Methoxy Cephalosporanic Acid 56796-16-8 C15H17N3O7S2
7S-Cefdinir 7S-Cefdinir 178601-89-3 C14H13N5O5S2
Dehydroxy BroMocelecoxib Dehydroxy BroMocelecoxib 170570-75-9 C17H13BrF3N3O2S
2-(3-Chloro-2-hydroxypropyl)-2H-isoindole-1,3-dione 2-(3-Chloro-2-hydroxypropyl)-2H-isoindole-1,3-dione 19667-37-9 C11H10ClNO3
4,6-Dibromo-m-cresol 4,6-Dibromo-m-cresol 13321-76-1 C7H6Br2O
4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O 4-(2,3-DIMETHYL-BENZYL)-1H-IMIDAZOLE HCL H2O 90038-00-9 C12H17ClN2O
Metoprolol Acid Ethyl Ester Metoprolol Acid Ethyl Ester 29112-40-1 C16H25NO4
6-Hydroxy Desloratadine 6-Hydroxy Desloratadine 119410-05-8 C19H19ClN2O
10-Acetyloxy Oxcarbazepine 10-Acetyloxy Oxcarbazepine 113952-21-9 C17H14N2O4
(S)-N-Demethyl Dapoxetine (S)-N-Demethyl Dapoxetine 147199-39-1 C20H21NO
Famotidine Related Compound A Hydrochloride Famotidine Related Compound A Hydrochloride 76833-47-1 C8H15ClN6S2
Des(trifluoroethyl) Lansoprazole Sulfide Des(trifluoroethyl) Lansoprazole Sulfide 131926-97-1 C14H13N3OS
Desulfo Aztreonam Desulfo Aztreonam 102579-59-9 C13H17N5O5S
Mosapride Citric Amide Mosapride Citric Amide 1215825-20-9 C27H31ClFN3O9
(1,2,4-Triazol-4-yl) Itraconazole (1,2,4-Triazol-4-yl) Itraconazole 854372-77-3 C35H38Cl2N8O4
6,7,8,9-Tetrahydro Carvedilol 6,7,8,9-Tetrahydro Carvedilol 1246820-73-4 C24H30N2O4
Cefdinir Lactone Cefdinir Lactone 946573-41-7 C14H13N5O5S2
Ozagrel methylester Ozagrel methylester 866157-50-8 C13H12N2O2
2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- 2-Propanol, 1-[2-(2-methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]- 163685-38-9 C15H25NO3
2-aMino-3-Methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butyric acid 2-aMino-3-Methyl-3-sulfino-4-(1H-1,2,3-triazol-1-yl)butyric acid 118175-11-4 C7H12N4O4S
1,4,8,11-Tetraazacy clotetradecance, 1,4,8-tris[(4 Methylphenyl)sufonyl]- 1,4,8,11-Tetraazacy clotetradecance, 1,4,8-tris[(4 Methylphenyl)sufonyl]- 104395-69-9 C31H42N4O6S3
(1S)-N-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-1,2,3,4-tetrahydro-1-naphthalenecarboxaMide (1S)-N-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-1,2,3,4-tetrahydro-1-naphthalenecarboxaMide 177793-79-2 C18H24N2O
(E)-Ceftriaxone (E)-Ceftriaxone 92143-31-2 C18H18N8O7S3
(Z)-Cinnarizine (Z)-Cinnarizine 750512-44-8 C26H28N2
Desethylene Norfloxacin Hydrochloride Desethylene Norfloxacin Hydrochloride 75001-77-3 C14H16FN3O3
p-(2,3-Epoxypropoxy)benzyl Alcohol p-(2,3-Epoxypropoxy)benzyl Alcohol 4204-78-8 C10H12O3
α-Etoposide α-Etoposide 100007-53-2 C29H32O13
N-Desmethyl-N-benzyl Sildenafil N-Desmethyl-N-benzyl Sildenafil 1446089-82-2 C28H34N6O4S
4-Hydroxy AtoMoxetine Oxalate 4-Hydroxy AtoMoxetine Oxalate 457634-21-8 C19H23NO6
6-Chloro-1-Ethyl-4-Oxo-7-(Piperazin-1-yl)-1,4-Dihydroquinoline-3-Carboxylic acid 6-Chloro-1-Ethyl-4-Oxo-7-(Piperazin-1-yl)-1,4-Dihydroquinoline-3-Carboxylic acid 67681-84-9 C16H18ClN3O3
Afatinib IMpurity J Afatinib IMpurity J 1456696-14-2 C18H22N4O4
Aprepitant iMpurity A Aprepitant iMpurity A
Atorvastatin LactaM Phenanthrene CalciuM Salt Atorvastatin LactaM Phenanthrene CalciuM Salt 1046378-58-8 C33H35CaFN2O6
Avanafil IMpurity 7 Avanafil IMpurity 7
Desfluoro flurbiprofen axetil Desfluoro flurbiprofen axetil 1685278-08-3 C19H20O4
Desloratadine IMpurity 6 Desloratadine IMpurity 6 38092-90-9 C20H21ClN2
ErtapeneM Ring Open IMpurity ErtapeneM Ring Open IMpurity
LincoMycin iMpurity C LincoMycin iMpurity C
Norfloxacin iMpurity E Norfloxacin iMpurity E
Posaconazole iMpurity 2 Posaconazole iMpurity 2
Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol] Quetiapine IMpurity [2-(2-Piperazin-1-yl)ethoxy)ethanol] 2206135-50-2 C25H18N2S2
Rabeprazole iMpurity (Chloro interMediate) Rabeprazole iMpurity (Chloro interMediate)
TaMsulosin IMpurity F TaMsulosin IMpurity F C20H28N2O5S
TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin) TiaMulin IMpurity E (TiaMulone,11-Oxo TiaMulin) 113323-39-0 C28H45NO4S
2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 2-(2-(4-(Dibenzo[b,f][1,4]thiazepin-11-yl)piperazin-1-yl)ethoxy)ethanol 848814-27-7 C21H27N3O3S
(3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester (3aR,7R,7aR)-2,2-Diethyl-3a,6,7,7a-tetrahydro-7-[(Methylsulfonyl)oxy]-1,3-benzodioxole-5-carboxylic Acid Ethyl Ester 204254-90-0 C15H24O7S
TorseMide Carboxylic Acid TorseMide Carboxylic Acid 113844-99-8 C16H18N4O5S
(3S,5R)-Fluvastatin SodiuM Salt (3S,5R)-Fluvastatin SodiuM Salt 94061-81-1 C24H25FNNaO4
(6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone (6-BroMo-2-ethyl-3-benzofuranyl)(3,5-dibroMo-4-hydroxyphenyl)Methanone 1402819-05-9 C17H11Br3O3
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