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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
Methyl 2-Acetyl-3-(3-nitrophenyl)-5-oxo-hexanoate Methyl 2-Acetyl-3-(3-nitrophenyl)-5-oxo-hexanoate 2469555-30-2 C15H17NO6
Dapagliflozin Impurity (MW: 425Da) Dapagliflozin Impurity (MW: 425Da)
Sugammadex Monochloro Impurity Sugammadex Monochloro Impurity
Oseltamivir Impurity (MW:468Da) Oseltamivir Impurity (MW:468Da)
Levothyroxine – Impurity 5 Levothyroxine – Impurity 5
Ibuprofen IPA impurity Ibuprofen IPA impurity
Kaempferol-3-rhamnoglucoside-7-glucoside Kaempferol-3-rhamnoglucoside-7-glucoside 34336-18-0 C33H40O20
Mupirocin iMpurity 2 Mupirocin iMpurity 2 C26H44O9
Cytarabine Impurity 10 Cytarabine Impurity 10 32830-01-6 C9H11N3O4
Ceftriaxone Sodium impurity 5 Ceftriaxone Sodium impurity 5
Sugammadex sodium Org48302 Impurity Sugammadex sodium Org48302 Impurity
176761-00-5 176761-00-5 176761-00-5 C17H15FN2O5
Pramipexole Impurity W Pramipexole Impurity W
Aprepitant Impurity 44 Aprepitant Impurity 44 172676-88-9 C23H21F7N4O3
Oseltamivir  Impurity 26 Oseltamivir Impurity 26 241465-24-7
Afatinib Impurity I Afatinib Impurity I
Moxifloxacin Impurity 5 Moxifloxacin Impurity 5
Moxifloxacin Impurity 24 Moxifloxacin Impurity 24
Fosaprepitant Impurity 1 Fosaprepitant Impurity 1
Ticagrelor Impurity 1 Ticagrelor Impurity 1
Ezetimibe Impurity 36 Ezetimibe Impurity 36
Pitavastatin Impurity 2 Pitavastatin Impurity 2
Fudosteine Impurity 2 Fudosteine Impurity 2
Sugammadex Impurity 18 Sugammadex Impurity 18
Mirabegron Impurity 21 Mirabegron Impurity 21
Apixaban Impurity 18 Apixaban Impurity 18 473927-65-0 C20H17IN4O3
Clopidogrel Impurity 12 Clopidogrel Impurity 12 C15H14ClNO2S
Oseltamivir Impurity 25 Oseltamivir Impurity 25
Ritonavir EP Impurity P Ritonavir EP Impurity P
Tacrolimus Impurity 4 Tacrolimus Impurity 4 686773-61-5 C44H69NO12
(2R,4S)-isopropyl5-([1,1'-biphenyl]-4-yl)-4-(2,5-dioxopyrrolidin-1- yl)-2-methylpentanoate (2R,4S)-isopropyl5-([1,1'-biphenyl]-4-yl)-4-(2,5-dioxopyrrolidin-1- yl)-2-methylpentanoate C25H29NO4
methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate hydrochloride methyl 3-(4-(2-hydroxy-3-(isopropylamino)propoxy)phenyl)-3- oxopropanoate hydrochloride C16H24ClNO5
Aprepitant iMpurity 37 Aprepitant iMpurity 37
Vitamin E Impurity 3 Vitamin E Impurity 3 1560705-69-2 C29H50O2
(trans)-phenyl3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)piperidine-1-carboxylate (trans)-phenyl3-((benzo[d][1,3]dioxol-5-yloxy)methyl)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)piperidine-1-carboxylate C32H28FNO5
arformoterol tartrate impurity arformoterol tartrate impurity
arformoterol tartrate impurity arformoterol tartrate impurity
Cefraprazole impurity Cefraprazole impurity
Afatinib Impurity QAQ Afatinib Impurity QAQ
Afatinib Impurity QAQ Afatinib Impurity QAQ
Afatinib Impurity SHO Afatinib Impurity SHO 2223677-65-2 C38H30Cl2F2N8O6
Afatinib Impurity SHO Afatinib Impurity SHO 2223677-65-2 C38H30Cl2F2N8O6
Androstan-17-one,3-[[(4-methylphenyl)sulfonyl]oxy]-,(3,5)- Androstan-17-one,3-[[(4-methylphenyl)sulfonyl]oxy]-,(3,5)- 10429-07-9 C26H36O4S
Cabozantinib Impurity 48 Cabozantinib Impurity 48 202916-99-2 C17H15NO3
Landiolol impurity R Landiolol impurity R
6-Oxo-Palonosetron 6-Oxo-Palonosetron 848074-10-2 C19H22N2O2
Teneligliptin Impurity 8 Teneligliptin Impurity 8
(trans)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)-1-methylpiperidin-3-yl) methanol (trans)-4-(4'-fluoro-[1,1'-biphenyl]-3-yl)-1-methylpiperidin-3-yl) methanol
2,4(1H,3H)-Pyrimidinedione, 3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-6-methyl- 2,4(1H,3H)-Pyrimidinedione, 3-[[2-fluoro-6-(trifluoromethyl)phenyl]methyl]-6-methyl- 2354391-45-8 C13H10F4N2O2
Cyclopropane, nitroso- Cyclopropane, nitroso- 28017-92-7 C3H5NO
Hyoscine Butylbromide EP Impurity D Hyoscine Butylbromide EP Impurity D
Carbetocin Impurity 1 Carbetocin Impurity 1
Carboprost Trometamol Impurity A Carboprost Trometamol Impurity A
Procaine Impurity 2 Procaine Impurity 2 C13H20N2O2
tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate tert-butyl 4-(6-((6-acetyl-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate 1651214-74-2 C29H37N7O4
Prasugrel Impurity 4 HCl Prasugrel Impurity 4 HCl 1618107-96-2 C20H22Cl2FNO3S
Tofacitinib Impurity K Tofacitinib Impurity K
N-(3-chloro-4-fluorophenyl)-7 -methoxy-6-(3-morpholinopropoxy)-N-(3-morpholinopropyl)quinazolin-4-amine N-(3-chloro-4-fluorophenyl)-7 -methoxy-6-(3-morpholinopropoxy)-N-(3-morpholinopropyl)quinazolin-4-amine 1502829-45-9 C29H37ClFN5O4
(S)-ethyl 3-((R)-5-oxopyrrolidine-2-carbonyl)thiazolidine-4-carboxylate(DD) (S)-ethyl 3-((R)-5-oxopyrrolidine-2-carbonyl)thiazolidine-4-carboxylate(DD)
Lincomycin EP Impurity B Lincomycin EP Impurity B 37744-65-3 C18H32N2O6S
Roxithromycin EP Impurity D Roxithromycin EP Impurity D 134931-00-3 C41H76N2O15
2-(pentan-3-yloxy)acetaldehyde 2-(pentan-3-yloxy)acetaldehyde 1141364-90-0 C7H14O2
Abiraterone Impurity 10 Abiraterone Impurity 10 165334-69-0 C26H33NO2
Cabozantinib Impurity B Cabozantinib Impurity B
Benzoic acid, 2-[(methylamino)sulfonyl]- Benzoic acid, 2-[(methylamino)sulfonyl]- 125372-22-7 C8H9NO4S
1-Piperazineethanol,4-[(2-chlorophenyl)(3-chlorophenyl)methyl]-, hydrochloride (1:2) 1-Piperazineethanol,4-[(2-chlorophenyl)(3-chlorophenyl)methyl]-, hydrochloride (1:2) 126517-38-2 C19H24Cl4N2O
Benzene,1-ethoxy-4-(phenylmethyl)- Benzene,1-ethoxy-4-(phenylmethyl)- 35672-52-7 C15H16O
Donepezil  Impurity Donepezil Impurity 36159-03-2 C22H22O5
tert-Butyl 4-(4-nitropyridin-3-yl)piperazine-1-carboxylate tert-Butyl 4-(4-nitropyridin-3-yl)piperazine-1-carboxylate 1774898-55-3 C14H20N4O4
4-(2-Aminophenoxy)-N-methylpicolinamide 4-(2-Aminophenoxy)-N-methylpicolinamide 1153328-25-6 C13H13N3O2
2-chloromethyl-4-(3-hydroxypropoxy)-3-methylpyridine 2-chloromethyl-4-(3-hydroxypropoxy)-3-methylpyridine 117976-92-8 C10H14ClNO2
8-Methoxy Entecavir 8-Methoxy Entecavir 2203740-23-0 C13H17N5O4
Bortezomib Impurity 32 Bortezomib Impurity 32 1310383-72-2 C17H31BF3NO5
Topiroxostat Impurity 14 Topiroxostat Impurity 14
1-Pyrrolidinecarboxylic acid, 4-hydroxy-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4S)- 1-Pyrrolidinecarboxylic acid, 4-hydroxy-2-(3-thiazolidinylcarbonyl)-, 1,1-dimethylethyl ester, (2S,4S)- 401564-34-9 C13H22N2O4S
Ampicillin Impurity B Ampicillin Impurity B
Clindamycin Phosphate EP Impurity K Clindamycin Phosphate EP Impurity K
UGDFSHGFPJSALM-OCKHKDLRSA-N UGDFSHGFPJSALM-OCKHKDLRSA-N 113806-01-2 C22H25NO3
Homoeriodictyol 7-O-glucoside Homoeriodictyol 7-O-glucoside 14982-11-7 C22H24O11
7,7'-(butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one) 7,7'-(butane-1,4-diylbis(oxy))bis(quinolin-2(1H)-one) 2116542-19-7 C22H20N2O4
Descyclopropyl Lenvatinib Descyclopropyl Lenvatinib 417719-51-8 C18H15ClN4O4
3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)-rel- 3-Piperidinemethanol, 4-(4-fluorophenyl)-1-methyl-, (3R,4R)-rel- 54088-21-0 C13H18FNO
1'-Hydroxy Bilastine 1'-Hydroxy Bilastine 1638785-23-5 C28H37N3O4
Brexpiprazole Impurity 4 Brexpiprazole Impurity 4 2116542-20-0 C25H27N3O2S
Fosaprepitant Impurity 5 Fosaprepitant Impurity 5 327623-35-8 C21H19F6NO3
Moxifloxacin Ethyl Ester Moxifloxacin Ethyl Ester 1403836-23-6 C23H28FN3O4
Pantoprazole Impurity 5 Pantoprazole Impurity 5 1806469-15-7 C8H6F2N2O2
Venlafaxine Impurity 5 Venlafaxine Impurity 5 1346600-77-8 C17H27NO2
N-(4-methyl-3-(4-methyl-6-(pyridin-3-yl)pyrimidin-2-ylamino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide N-(4-methyl-3-(4-methyl-6-(pyridin-3-yl)pyrimidin-2-ylamino)phenyl)-4-((4-methylpiperazin-1-yl)methyl)benzamide C30H33N7O
Exemestane impurity B -F Exemestane impurity B -F 184972-09-6 C20H26O3
Fesoterodine Impurity 8 Fesoterodine Impurity 8 1380491-71-3 C48H66N2O4
QBWNUEJPRUVNTD-FOIQADDNSA-N QBWNUEJPRUVNTD-FOIQADDNSA-N 1346602-17-2 C22H17N3O5
JZWUWLJCMMPASK-YTSMVRMISA-N JZWUWLJCMMPASK-YTSMVRMISA-N 147103-95-5 C24H24N4O7S
KXEITTOLAUJQPU-UHFFFAOYSA-N KXEITTOLAUJQPU-UHFFFAOYSA-N 1797832-43-9 C20H21N7O2S
GPZGXSFHPLUMHE-KEUNHQLVSA-N GPZGXSFHPLUMHE-KEUNHQLVSA-N 157054-84-7 C52H81NO13
IRLGOHSHDYCIAB-ZMVBZRCWSA-N IRLGOHSHDYCIAB-ZMVBZRCWSA-N 1076198-14-5 C19H23F3N2O5
AOEGVETYSHPGBP-XYIDDFOTSA-N AOEGVETYSHPGBP-XYIDDFOTSA-N 1887057-05-7 C41H55NO14
4,6-DIAMINOINDAZOLE 4,6-DIAMINOINDAZOLE 885518-52-5 C7H8N4
12-Deoxy Roxithromycin 12-Deoxy Roxithromycin 425365-65-7 C41H76N2O14
1-(1-oxidopyridin-1-ium-2-yl)-1-phenylethanol 1-(1-oxidopyridin-1-ium-2-yl)-1-phenylethanol 100393-43-9 C13H13NO2
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