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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(S)-Hydroperoxy Simvastatin 3(S)-Hydroperoxy Simvastatin 1092716-44-3 C25H38O7
2(RS)-4-Methyl-1-(3-Methylpyridin-2-yl)-2-phenylpiperazine 2(RS)-4-Methyl-1-(3-Methylpyridin-2-yl)-2-phenylpiperazine 191546-94-8 C17H21N3
REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane REF DUPL: trans-2-Hydroxymethyl-5-(cytosin-1-yl)-1,3-oxathiolane 139757-68-9 C8H11N3O3S
(S)-N-Didemethyl Dapoxetine (S)-N-Didemethyl Dapoxetine 147199-40-4 C19H19NO
Hydroxy Flunarizine Hydroxy Flunarizine 87166-81-2 C26H26F2N2O
1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 1-METHYL-4-NITRO-3-PROPYL-1H-PYRAZOLE-5-CARBOXYLIC ACID 139756-00-6 C8H11N3O4
6-Hydroxy Nicorandil 6-Hydroxy Nicorandil 113743-17-2 C8H9N3O5
trans-Itraconazole trans-Itraconazole 252964-65-1 C35H38Cl2N8O4
N-(2-Pyridyl)oxamic Acid N-(2-Pyridyl)oxamic Acid 13120-39-3 C7H6N2O3
(trans)-4-Propyl-1-methyl-L-proline (trans)-4-Propyl-1-methyl-L-proline 13380-36-4 C9H17NO2
N-Nordextromethorphan
N-Nordextromethorphan 1531-23-3 C17H23NO
(S,S,R,R)-Orlistat (S,S,R,R)-Orlistat 111466-62-7 C29H53NO5
17β-Carboxy-17-desoxy Dexamethasone 17β-Carboxy-17-desoxy Dexamethasone 75262-69-0 C21H27FO4
1-(dimethoxymethyl)-3-methoxybenzene 1-(dimethoxymethyl)-3-methoxybenzene 59276-28-7 C10H14O3
Benazepril impurity A Benazepril impurity A C24H28N2O5
3S,4R-4-[phenyl-1-methylpiperidinyl] methanol 3S,4R-4-[phenyl-1-methylpiperidinyl] methanol 176022-03-0 C13H19NO
Allopurinol Related CoMpound F Allopurinol Related CoMpound F 321571-07-7 C12H14N4O4
N-[(n-butylaMino)carbonyl]-4-[(3-Methylphenyl)aMino]-3-pyridinesulfonaMide N-[(n-butylaMino)carbonyl]-4-[(3-Methylphenyl)aMino]-3-pyridinesulfonaMide 160972-33-8 C17H22N4O3S
(R)-N-DeMethyl Dapoxetine (R)-N-DeMethyl Dapoxetine 1202160-36-8 C20H21NO
14,15-Dehydro Budesonide 14,15-Dehydro Budesonide 131918-64-4 C25H32O6
2-(BenzylMethylaMino)-3',4'-dihydroxyacetophenone 2-(BenzylMethylaMino)-3',4'-dihydroxyacetophenone 36467-25-1 C16H17NO3
2'-O-(5'-Deoxy-β-D-ribofuranosyl) Capecitabine 2'-O-(5'-Deoxy-β-D-ribofuranosyl) Capecitabine 1262133-66-3 C20H30FN3O9
4-Defluoro-4-hydroxy Gefitinib 4-Defluoro-4-hydroxy Gefitinib 847949-50-2 C22H25ClN4O4
Desethyl Sildenafil Desethyl Sildenafil 139755-91-2 C20H26N6O4S
N-Desisopropyl-N-forMyl Bisoprolol N-Desisopropyl-N-forMyl Bisoprolol 1346602-59-2 C16H25NO5
N-DesMethyl Olopatadine N-DesMethyl Olopatadine 113835-92-0 C20H21NO3
10-Keto DextroMethorphan 10-Keto DextroMethorphan 57969-05-8 C18H23NO2
2'-[(1H-Tetrazol-5-yl)biphenyl-4-yl]Methanol 2'-[(1H-Tetrazol-5-yl)biphenyl-4-yl]Methanol 160514-13-6 C14H12N4O
3''-HABA KanaMycin A 3''-HABA KanaMycin A 50725-25-2 C22H43N5O13
ent-Paroxol ent-Paroxol 389573-45-9 C13H18FNO
Ethyl α-Thioglucopyranoside Ethyl α-Thioglucopyranoside 13533-58-9 C8H16O5S
Febuxostat Acyl-β-D-glucuronide Febuxostat Acyl-β-D-glucuronide 1351692-92-6 C22H24N2O9S
Keto Bisoprolol Keto Bisoprolol 864544-37-6 C18H29NO5
Olopatadine Carbaldehyde  DISCONTINUED Olopatadine Carbaldehyde DISCONTINUED 1376615-97-2 C21H23NO2
5-Chloro-1-methyl-4-nitroimidazole 5-Chloro-1-methyl-4-nitroimidazole C4H4ClN3O2
Nisoldipine Related Compound  II Nisoldipine Related Compound II
AgoMelatine DiMer Urea AgoMelatine DiMer Urea 185421-27-6 C27H28N2O3
AgoMelatine DiMer Urea AgoMelatine DiMer Urea 185421-27-6 C27H28N2O3
Isotachysterol3 Isotachysterol3 22350-43-2 C27H44O
Nitrendipine Propyl Ester Nitrendipine Propyl Ester 225785-54-6 C19H22N2O6
O-DesMethyl Urapidil O-DesMethyl Urapidil 91453-03-1 C19H27N5O3
(1R,3R,4R)-Entecavir (1R,3R,4R)-Entecavir 1367369-76-3 C12H15N5O3
5-(5-chloro-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 5-(5-chloro-1-(2-fluorophenyl)-2-oxopentyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate 1056459-37-0 C20H21ClFNO3S
(2S,3R)-2-((S)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-3-(4-fluorophenyl)Morpholine (2S,3R)-2-((S)-1-(3,5-bis(trifluoroMethyl)phenyl)ethoxy)-3-(4-fluorophenyl)Morpholine 327623-37-0 C20H18F7NO2
Linagliptin iMpurity Linagliptin iMpurity 2140263-92-7 C25H28N8O2
1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxaMide 1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxaMide 256376-62-2 C14H11FN4O
Alogliptin iMpurity Alogliptin iMpurity 60271-06-9 C7H10N2O3
Alogliptin iMpurity Alogliptin iMpurity 60271-06-9 C7H10N2O3
cefaclor iMpurity H cefaclor iMpurity H C4H6N4O3S2
Tadalafil iMpurity E Tadalafil iMpurity E
3,3',5-TRIIODOTHYROPROPIONIC ACID 3,3',5-TRIIODOTHYROPROPIONIC ACID 51-26-3 C15H11I3O4
Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) Cytidine,N-benzoyl-2^-C-Methyl-,3^,5^-dibenzoate(9CI) 863329-64-0 C31H27N3O8
(R)-2-((6-(3-((3-(2-cyanobenzyl)-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)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-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)benzonitrile 1268836-55-0 C31H30N8O4
(R)-2-((6-(3-((3-(2-cyanobenzyl)-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)benzonitrile (R)-2-((6-(3-((3-(2-cyanobenzyl)-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)benzonitrile 1268836-55-0 C31H30N8O4
Moxifloxacin Methyl Ester Moxifloxacin Methyl Ester 721970-35-0 C22H26FN3O4
Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride) Atomoxetine Related Compound C (10 mg) (N-methyl-3-phenyl-3-(p-tolyloxy)propan-1-amine hydrochloride) 873310-31-7 C17H22ClNO
Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide) Dofetilide Related Compound A (25 mg) (N-[4-(2-(2-[4-(methanesulfonamido)phenoxy]ethyl)amino)phenyl]methanesulfonamide) 176447-94-2 C18H25N3O5S2
5-Methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid 5-Methyl-2-(1H-1,2,3-triazol-1-yl)benzoic acid 1149352-55-5 C10H9N3O2
9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 1256584-80-1 C21H17IN2O
9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 9-ethyl-8-iodo-6,6-diMethyl-11-oxo-6,11-dihydro-5H-benzo[b]carbazole-3-carbonitrile 1256584-80-1 C21H17IN2O
ForMaMide, N-[5-(2R)-oxiranyl-2-(phenylMethoxy)phenyl]- ForMaMide, N-[5-(2R)-oxiranyl-2-(phenylMethoxy)phenyl]- 201677-57-8 C16H15NO3
2-(MethylcarbaMoyl)benzoic acid 2-(MethylcarbaMoyl)benzoic acid 6843-36-3 C9H9NO3
1-(4-(2-Methoxyethyl)phenoxy)-3-(oxiran-2-ylMethoxy)propan-2-ol 1-(4-(2-Methoxyethyl)phenoxy)-3-(oxiran-2-ylMethoxy)propan-2-ol 1416440-64-6 C15H22O5
(3S,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine (3S,4S)-1-benzyl-N,4-diMethylpiperidin-3-aMine 1354621-59-2 C14H22N2
1H-BenziMidazole-7-carboxylic acid, 1-[[2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]Methyl] -2-ethoxy-, ethyl ester 1H-BenziMidazole-7-carboxylic acid, 1-[[2'-(2,5-dihydro-5-oxo-1,2,4-oxadiazol-3-yl)[1,1'-biphenyl]-4-yl]Methyl] -2-ethoxy-, ethyl ester 1403474-70-3 C27H24N4O5
6-acetyl-2-aMino-8-cyclopentyl-5-Methylpyrido[2,3-d]pyriMidin-7(8H)-one 6-acetyl-2-aMino-8-cyclopentyl-5-Methylpyrido[2,3-d]pyriMidin-7(8H)-one 571189-64-5 C15H18N4O2
Apixaban-13C-D3 Apixaban-13C-D3 1261393-15-0 C2413CH22D3N5O4
IMp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]-CarbaMate IMp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]-CarbaMate
IMp. C (EP): Methyl-2-[4-[2-[(4-Chlorobenzoyl)aMino]ethyl]phenoxy]-2-Methylpropanoate IMp. C (EP): Methyl-2-[4-[2-[(4-Chlorobenzoyl)aMino]ethyl]phenoxy]-2-Methylpropanoate
5-PyriMidinecarboxylic acid, 4-(4-fluorophenyl)-1,2-dihydro-6-(1-Methylethyl)-2-oxo-, Methyl ester 5-PyriMidinecarboxylic acid, 4-(4-fluorophenyl)-1,2-dihydro-6-(1-Methylethyl)-2-oxo-, Methyl ester 488798-37-4 C15H15FN2O3
1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1-Pyrrolidinecarboxylic acid, 4-oxo-2-(3-thiazolidinylcarbonyl)-, 1,1-diMethylethyl ester, (2R)- 1415908-67-6 C13H20N2O4S
(2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(phenyl)Morpholine hydrochloride (2R,3S)-2-[(1R)-1-[3,5-Bis(trifluoroMethyl)phenyl]ethoxy]-3-(phenyl)Morpholine hydrochloride 874460-46-5 C20H20ClF6NO2
AlMotriptan iMpurity AlMotriptan iMpurity
AlMotriptan iMpurity AlMotriptan iMpurity
FaMotidine iMpurity FaMotidine iMpurity 130463-35-3 C5H8N4S2.Na
Nitrendipine iMpurity Nitrendipine iMpurity
TraMadol EP IMpurity-C TraMadol EP IMpurity-C 66170-31-8 C16H24ClNO
tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate 1210348-34-7 C16H29N3O7
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) 1338800-82-0 C17H20N4O2
Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) Anastrozole IMpurity (3-(1-Cyano-1-Methylethyl)-alfa,alfa-diMethyl-5-(1H-,1,2,4-triazole-1-ylMethyl)-benzeneacetic acid) 1338800-82-0 C17H20N4O2
AtracuriuM IMpurity K (Mixture of cis, trans, cis, cis(K1 & K2), tans, trans IsoMer) AtracuriuM IMpurity K (Mixture of cis, trans, cis, cis(K1 & K2), tans, trans IsoMer)
ChlorphenaMine IMpurity B ChlorphenaMine IMpurity B
Clozapine EP IMpurity D Clozapine EP IMpurity D 65514-71-8 C18H21ClN4O
Febuxostat IMpurity (2-(3-carboxy-4-isobutyloxyphenyl)-4-Methylthiazole-5-carboxylic acid) Febuxostat IMpurity (2-(3-carboxy-4-isobutyloxyphenyl)-4-Methylthiazole-5-carboxylic acid)
Fluconazole IMpurity I Fluconazole IMpurity I C13H12F2N6O
IMidafenacin Related CoMpound 1 (4-(1H-IMidzol-1-yl)-2,2-DiphenylbutanaMide) IMidafenacin Related CoMpound 1 (4-(1H-IMidzol-1-yl)-2,2-DiphenylbutanaMide) 170105-20-1 C19H19N3O
IMidafenacin Related CoMpound 6 (4-AcetiMidoylaMino-2,2-DiphenylbutanaMide) IMidafenacin Related CoMpound 6 (4-AcetiMidoylaMino-2,2-DiphenylbutanaMide) 503598-33-2 C18H21N3O
Lansoprazole IMpurity H Lansoprazole IMpurity H 1346598-28-4 C23H16F3N5OS
LevetiracetaM IMurity (L-2-AMinobutanaMide HCl,S-2-AMinobutanaMide HCl) LevetiracetaM IMurity (L-2-AMinobutanaMide HCl,S-2-AMinobutanaMide HCl) 1933471-30-7 C8H14N2O3
Milrinone IMpurity 4 Milrinone IMpurity 4
Nebivolol O-Beta-D-Glucuronide Nebivolol O-Beta-D-Glucuronide 1698091-61-0 C22H27NO4
Nicergoline IMp. C (EP) Nicergoline IMp. C (EP)
Perindopril IMpurity E Perindopril IMpurity E
Pitavastatin 3-Oxo SodiuM Pitavastatin 3-Oxo SodiuM 2245811-12-3 C25H22FNO4
PraMipexole IMp.BI-II828BS PraMipexole IMp.BI-II828BS C20H32N6S2
Propofol IMpurity F Propofol IMpurity F
Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt) Rosuvastatin IMpurity SodiuM Salt (5-Oxo Rosuvastatin SodiuM Salt) 1422619-13-3 C22H26FN3O6S
Sertraline IMpurity (SRTRC-3) Sertraline IMpurity (SRTRC-3) 91797-76-1 C17H17Cl2N
Terbutaline IMpurity B Terbutaline IMpurity B 94120-05-5 C13H19NO3
Benzoic acid, 4-[(4-Methyl-1-piperazinyl)Methyl]-3-(trifluoroMethyl)- Benzoic acid, 4-[(4-Methyl-1-piperazinyl)Methyl]-3-(trifluoroMethyl)- 859282-11-4 C14H17F3N2O2
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