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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
Pidotimod Impurity P Pidotimod Impurity P
Pitavastatin Impurity 11 Pitavastatin Impurity 11
Pramipexole Impurity 18 Pramipexole Impurity 18
Tenofovir disoproxil Impurity 18 Tenofovir disoproxil Impurity 18
Tenofovir Impurity 50 Tenofovir Impurity 50
Darunavir Darunavir 1526916-57-3 C22H31N3O5S
(S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran (S)-3-(4-(2,5-dibromobenzyl)phenoxy)tetrahydrofuran C17H16Br2O2
[4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate [4-[2-[(4-chlorobenzoyl)amino]ethyl]phenyl] 4-chlorobenzoate 41859-56-7 C22H17Cl2NO3
1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride 1-(2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl)piperazine hydrochloride 70918-74-0 C13H17ClN2O3
N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE N-(2,4-DICHLORO-5-HYDROXYPHENYL)ACETAMIDE 67669-19-6 C8H7Cl2NO2
Metronidazole Impurity 2 Metronidazole Impurity 2
ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5-
carboxylate ethyl 2-(3-cyano-4-isopropoxyphenyl)-4-methylthiazole-5- carboxylate 144060-84-4 C17H18N2O3S
Dasatinib Impurity 24 Dasatinib Impurity 24
Pregabalin Impurity 19 Pregabalin Impurity 19 89015-27-0 C11H14O3
Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside Quercetin 3-O-(6''-galloyl)-β-D-glucopyranoside 56316-75-7 C28H24O16
2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE 2-CHLOROMETHYL-3-METHYL-4-(2,2,2-TRIFLUOROETHOXY)PYRIDINE 128430-66-0 C9H9ClF3NO
N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide N-[1-(4-methoxyphenyl)-2-methylpropan-2-yl]acetamide 926319-54-2 C13H19NO2
Cetirizine EP Impurity B(base) Cetirizine EP Impurity B(base) 942193-17-1 C19H21ClN2O2
Dezocine Impurity 3 Dezocine Impurity 3 100667-16-1 C16H21NO2
Ertapenem Impurity 10 Ertapenem Impurity 10 357154-27-9 C22H27N3O8S
loteprednol Impurity 8 loteprednol Impurity 8 207670-54-0 C24H29ClO7
Nimodipine Impurity 4 Nimodipine Impurity 4 74936-69-9 C18H20N2O6
Paroxetine Impurity 45 Paroxetine Impurity 45 1396174-70-1 C19H20FNO3
Tazobactam Impurity 5 Tazobactam Impurity 5 115546-67-3 C21H20ClNO3S
Tigecycline Impurity 2 Tigecycline Impurity 2 1422262-97-2 C29H39N5O8
Empagliflozin Impurity 34 Empagliflozin Impurity 34
Sugammadex Impurity 22 Sugammadex Impurity 22 2412952-94-2 C72H113NaO48S8
Febuxostat Febuxostat 1312815-36-3 C20H25NO4S
Itraconazole Impurity 34 Itraconazole Impurity 34 103661-14-9 C14H15Cl2N3O5S
Lansoprazole Impurity 34 Lansoprazole Impurity 34 1357726-93-2 C7H8N2O3
Meloxicam Impurity 1 HCl Meloxicam Impurity 1 HCl 929568-25-2 C4H7ClN2O
Palonosetron Impurity 11 Palonosetron Impurity 11 2216753-67-0 C18H24N2O
Dapagliflozin Impurity 10 Dapagliflozin Impurity 10 461432-27-9 C21H25ClO7
Levetiracetam impurity 2 Levetiracetam impurity 2 1341459-52-6 C8H17N3O2
(S)-5-chloro-N-(3-(5-chlorothiophene-2-carboxamido)-2- hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)thiophene-2- carboxamide (S)-5-chloro-N-(3-(5-chlorothiophene-2-carboxamido)-2- hydroxypropyl)-N-(4-(3-oxomorpholino)phenyl)thiophene-2- carboxamide 2204368-63-6 C23H21Cl2N3O5S2
Ezetimibe Impurity 38 Ezetimibe Impurity 38 1701462-59-0 C45H58F2N2O5Si2
Indapamide Impurity F Indapamide Impurity F 62574-66-7 C7H3Cl3O3S
Moxifloxacin Impurity 38 Moxifloxacin Impurity 38 1262758-66-6 C21H24FN3O5
Nimodipine  Impurity 3 Nimodipine Impurity 3 101072-61-1 C11H9NO5
Pitavastatin Impurity 40 Pitavastatin Impurity 40
Ritonavir EP Impurity R Ritonavir EP Impurity R
Ticagrelor Impurity 68 Ticagrelor Impurity 68 1643378-46-4 C23H29FN6O4S
Tofacitinib Impurity 70 Tofacitinib Impurity 70
Afatinib Impurity 22 Afatinib Impurity 22
Amifostine Impurity 6 Amifostine Impurity 6
Apixaban Impurity 33 Apixaban Impurity 33
Aztreonam Impurity 6 Aztreonam Impurity 6
Clarithromycin Impurity EP G Clarithromycin Impurity EP G 107216-09-1 C39H72N2O13
Dapagliflozin Impurity 32 Dapagliflozin Impurity 32
Doxofylline Impurity 7 Doxofylline Impurity 7 43135-57-5 C13H20N4O4
Erlotinib Impurity 55 Erlotinib Impurity 55
Etoposide Impurity 1 Etoposide Impurity 1
Etoposide Impurity 6 Etoposide Impurity 6
Olaparib Impurity 34 Olaparib Impurity 34
1-METHYL-5-MERCAPTOTETRAZOLE, SODIUM SALT 1-METHYL-5-MERCAPTOTETRAZOLE, SODIUM SALT 51138-06-8 C2H3N4NaS
5-HYDROXY LANSOPRAZOLE 5-HYDROXY LANSOPRAZOLE 131926-98-2 C16H14F3N3O3S
ergosteryl 3-beta-D-glucoside ergosteryl 3-beta-D-glucoside 130155-33-8 C34H54O6
(3S,5R)-4-[5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-2-oxopyrrolidin-1-yl]-4-oxobutanoic acid (3S,5R)-4-[5-([1,1'-Biphenyl]-4-ylmethyl)-3-methyl-2-oxopyrrolidin-1-yl]-4-oxobutanoic acid C22H23NO4
Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-4-[4-(propan-2-yloxy)-4-oxobutanamido]-2-methylbutanoate Ethyl (2R,4S)-4-([1,1'-biphenyl]-4-ylmethyl)-4-[4-(propan-2-yloxy)-4-oxobutanamido]-2-methylbutanoate C27H35NO5
Ethanone, 1-[3,5-bis(phenylmethoxy)phenyl]-2-[(1,1-dimethylethyl)(phenylmethyl)amino]-, sulfate (1:1) Ethanone, 1-[3,5-bis(phenylmethoxy)phenyl]-2-[(1,1-dimethylethyl)(phenylmethyl)amino]-, sulfate (1:1) 52144-93-1 C33H37NO7S
Cabozantinib Impurity H Cabozantinib Impurity H
Clopidogrel Impurity 11 Clopidogrel Impurity 11 C15H14ClNO2S
Medetomidine Impurity 3 Medetomidine Impurity 3 104245-83-2 C10H13Cl
Tofacitinib Impurity 35 Tofacitinib Impurity 35
Notoginsenoside FP2 Notoginsenoside FP2 1004988-75-3 C58H98O26
ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate ethyl 4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonate 1884279-18-8 C18H17NO4S
N-methyl-1-(5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methanamine fumarate N-methyl-1-(5-phenyl-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)methanamine fumarate 928325-82-0 C21H21N3O6S
Phenol, 2,4-dibromo-3-methyl- Phenol, 2,4-dibromo-3-methyl- 13321-75-0 C7H6Br2O
N-((4-FLUOROPHENYL)METHYL)ETHANAMIDE N-((4-FLUOROPHENYL)METHYL)ETHANAMIDE 86010-68-6 C9H10FNO
Benzenediazonium, 4-(ethoxycarbonyl)-, chloride Benzenediazonium, 4-(ethoxycarbonyl)-, chloride 2028-79-7 C9H9ClN2O2
2,4-Pteridinediamine,6-(methoxymethyl)- 2,4-Pteridinediamine,6-(methoxymethyl)- 40110-13-2 C8H10N6O
Fingolimod EP Impurity D Fingolimod EP Impurity D 780729-32-0 C21H37NO2
Pentanedioic acid, 2,4-diacetyl-3-(3-nitrophenyl)-, dimethyl ester Pentanedioic acid, 2,4-diacetyl-3-(3-nitrophenyl)-, dimethyl ester 89080-61-5 C17H19NO8
2-Thiazoleacetic acid,4-carboxy-2,5-dihydro-5-(4-hydroxybutylidene)-a-[(1R)-1-hydroxyethyl]-, disodium salt, (aS,2R,5Z)- (9CI) 2-Thiazoleacetic acid,4-carboxy-2,5-dihydro-5-(4-hydroxybutylidene)-a-[(1R)-1-hydroxyethyl]-, disodium salt, (aS,2R,5Z)- (9CI) 130609-10-8 C12H18NNaO6S
4,4'-Iminodiphenol hydrochloride 4,4'-Iminodiphenol hydrochloride 1965310-24-0 C12H12ClNO2
Cefradine Impurity D Cefradine Impurity D
WIXOVOWSUCEDGS-UHFFFAOYSA-N WIXOVOWSUCEDGS-UHFFFAOYSA-N 1346603-05-1 C15H20O5
YXSRVOWUJUXDLJ-UHFFFAOYSA-N YXSRVOWUJUXDLJ-UHFFFAOYSA-N 1618107-97-3 C18H18FNO2S
S-2-Benzothiazolyl-2-amino-±-(methoxyimino)-4-thiazolethiolacetate S-2-Benzothiazolyl-2-amino-±-(methoxyimino)-4-thiazolethiolacetate 1684396-27-7 C13H10N4O2S3
4-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-cyclopentene-1-carboxylic acid methyl ester 4-[[(1,1-Dimethylethoxy)carbonyl]amino]-2-cyclopentene-1-carboxylic acid methyl ester 168683-02-1 C12H19NO4
KNKJEUNXMFFFDU-LZHIOSKDSA-N KNKJEUNXMFFFDU-LZHIOSKDSA-N 138804-88-3 C25H34O6
MONO-DESACETYL FAMCICLOVIR MONO-DESACETYL FAMCICLOVIR 104227-88-5 C12H17N5O3
(E)-5-(2-CARBOXYVINYL)-2'-DEOXYURIDINE (E)-5-(2-CARBOXYVINYL)-2'-DEOXYURIDINE 74131-06-9 C12H14N2O7
HHUBRUYPYDODRB-UHFFFAOYSA-N HHUBRUYPYDODRB-UHFFFAOYSA-N 106860-70-2 C8H5NO5
5-Decyano 5-(Ethyl Formate) Milrinone 5-Decyano 5-(Ethyl Formate) Milrinone 80442-07-5 C14H14N2O3
25-DESACETYL RIFAMPICIN 25-DESACETYL RIFAMPICIN 16783-99-6 C41H56N4O11
ETHYL 2-CYCLOHEXYL-2-HYDROXY-PHENYLACETATE ETHYL 2-CYCLOHEXYL-2-HYDROXY-PHENYLACETATE 31197-69-0 C16H22O3
1-(4-methoxyphenyl)-2-methylpropan-2-ol 1-(4-methoxyphenyl)-2-methylpropan-2-ol 35144-39-9 C11H16O2
Apixaban Impurity 33 Apixaban Impurity 33 1686149-78-9 C21H27N3O3
1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 1,8-bis(4-((1,4,8,11-tetraazacyclotetradecan-1-yl)methyl)benzyl)-1,4,8,11-tetraazacyclotetradecane 414858-02-9 C46H84N12
butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate butyl 3-((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropanoate 2227199-31-5 C20H29N5O3
ethyl 2-((E)-5-((E)-2-methyl-3-phenylallylidene)-4-oxo-2-thioxothiazolidin-3-yl)acetate ethyl 2-((E)-5-((E)-2-methyl-3-phenylallylidene)-4-oxo-2-thioxothiazolidin-3-yl)acetate 682775-71-9 C17H17NO3S2
Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide 24683-26-9 C12H13NO5S
Sugammadex Sugammadex 1378831-29-8 C6H10O3S2
Petunidin 3-O-glucoside Petunidin 3-O-glucoside 71991-88-3 C22H23O12+
Oseltamivir Impurity 15 Oseltamivir Impurity 15 2254819-34-4 C22H36N2O4
Oseltamivir Impurity 27 Oseltamivir Impurity 27
Pitavastatin Impurity 20 Pitavastatin Impurity 20
Rocuronium Bromide Impurity 20 Rocuronium Bromide Impurity 20
Rocuronium Bromide Impurity 9 Rocuronium Bromide Impurity 9
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