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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
Bupivacaine  Impurity Bupivacaine Impurity 852804-30-9 C22H37N2O
Pseudomonic Acid D Pseudomonic Acid D 85248-93-7 C26H42O9
Terazosin Impurity Terazosin Impurity 60548-08-5 C19H25N5O4
1204612-29-2 1204612-29-2 1204612-29-2 C12H18ClNO2
(S)-3-(dimethylamino)-1-(thiophen-3-yl)propan-1-ol (S)-3-(dimethylamino)-1-(thiophen-3-yl)propan-1-ol 1384080-56-1 C9H15NOS
BDJS-SH 4 BDJS-SH 4 36588-46-2 C12H18N2O2
3-Chloro TirofiBan 3-Chloro TirofiBan 2713130-63-1 C22H35ClN2O5S
Adefovir Dipivoxil Impurity E Adefovir Dipivoxil Impurity E 116384-54-4 C10H16N5O4P
Apixaban Impurity 21 Apixaban Impurity 21
Atorvastatin Impurity 22 Atorvastatin Impurity 22 1821498-27-4 C27H30FNO6
Azelastine EP Impurity E Azelastine EP Impurity E 105279-16-1 C15H9ClO2
Blonanserin impurity F Blonanserin impurity F
Capecitabine Impurity 9 Capecitabine Impurity 9
Carfilzomib Impurity E Carfilzomib Impurity E
Cefoxitin EP Impurity B Cefoxitin EP Impurity B
Dabigatran Impurity 3 Dabigatran Impurity 3
Dexamethasone EP Impurity K Dexamethasone EP Impurity K 1809224-82-5 C22H26O4
Esomeprazole Impurity 3 Esomeprazole Impurity 3 1346599-85-6 C26H30N4O4S
FeBuxostat Impurity 41 FeBuxostat Impurity 41 2428631-67-6 C19H19N3O3S
Formoterol EP Impurity E Formoterol EP Impurity E 1616967-26-0 C20H26N2O4
Formoterol Impurity 16 Formoterol Impurity 16
Indacaterol Impurity 11 Indacaterol Impurity 11
Isavuconazole Impurity 14 Isavuconazole Impurity 14
Isavuconazole Impurity 19 Isavuconazole Impurity 19
Isavuconazole Impurity 24 Isavuconazole Impurity 24 1176988-44-5 C22H17F2N5OS
Letrozole Impurity 10 Letrozole Impurity 10
Levofloxacin Impurity 9 Levofloxacin Impurity 9 1797099-76-3 C18H20FN3O4
N-(5-Formyl-2-hydroxyphenyl)formamide N-(5-Formyl-2-hydroxyphenyl)formamide 903563-43-9 C8H7NO3
Nitrendipine Impurity 5 Nitrendipine Impurity 5
Posaconazole Impurity 32 Posaconazole Impurity 32
Posaconazole Impurity 61 Posaconazole Impurity 61
Procaterol Impurity 4 Procaterol Impurity 4 63235-39-2 C16H20N2O3
Sitagliptin Impurity 14 Sitagliptin Impurity 14 2072867-07-1 C26H23F9N6O2
SofosBuvir Impurity 31 SofosBuvir Impurity 31
sofosBuvir Impurity 37 sofosBuvir Impurity 37
SofosBuvir Impurity 53 SofosBuvir Impurity 53 1015255-46-5 C20H25FN3O9P
Sofosbuvir Impurity 60 Sofosbuvir Impurity 60
Tenofovir impurity G Tenofovir impurity G
Ticagrelor Impurity 26 Ticagrelor Impurity 26 2245167-79-5 C21H24F2N6O3S
Vildagliptin Impurity 19 Vildagliptin Impurity 19 243145-00-8 C10H16N2O2
Olopatadine Isopropyl ester Hydrochloride Olopatadine Isopropyl ester Hydrochloride 1206456-44-1 C24H29NO3
GLATIRAMER impurity GLATIRAMER impurity
Amoxicillin Impurity  U Amoxicillin Impurity U C16H19N3O5S
Amoxicillin Impurity  U Amoxicillin Impurity U C16H19N3O5S
Oxacillin Sodium Impurity I(EP) Oxacillin Sodium Impurity I(EP)
Spectinomycin Impurity E Spectinomycin Impurity E
3-butyl-3-hydroxy-2-benzofuran-1-one 3-butyl-3-hydroxy-2-benzofuran-1-one 162050-42-2 C12H14O3
(4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (minocycline) (4S,4aS,5aR,12aS)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide (minocycline)
(R)-10-(2,4,5-trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione (R)-10-(2,4,5-trifluorobenzyl)-3-(trifluoromethyl)-6,7,10,11-tetrahydro-[1,2,4]triazolo[3,4-c][1,4,7]triazecine-8,12(5H,9H)-dione 2088771-61-1 C16H13F6N5O2
N-((3R,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine N-((3R,4S)-1-benzyl-4-methylpiperidin-3-yl)-N-methyl-7H-pyrrolo[2,3-d]pyrimidin-4-amine 1092578-45-4 C20H25N5
846023-56-1 846023-56-1 846023-56-1 C26H31Cl2N5O4
Prednisone impurity D (EP) Prednisone impurity D (EP) 10184-69-7 C21H26O4
Lisinopril EP Impurity G Lisinopril EP Impurity G 1356839-89-8 C42H60N6O9
2-hexanoylbenzoic acid 2-hexanoylbenzoic acid 857538-11-5 C13H16O3
Blonanserin N-Oxide Blonanserin N-Oxide 142838-82-2 C23H30FN3O
Levofloxacin Impurity 11 Levofloxacin Impurity 11 106939-42-8 C9H9F2NO
Rabeprazole Impurity 2 Rabeprazole Impurity 2 1807988-36-8 C18H19N3O4
Tenofovir Related Compound 14 Tenofovir Related Compound 14 1244022-52-3 C8H11N5O
N-(2-methyl-5-nitrophenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide N-(2-methyl-5-nitrophenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)acetamide C18H15N5O3
N-(5-(benzyl(methyl)amino)-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide N-(5-(benzyl(methyl)amino)-2-methylphenyl)-N-(4-(pyridin-3-yl)pyrimidin-2-yl)formamide C25H23N5O
1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxylic acid 1-(2-fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboxylic acid 956011-26-0 C14H10FN3O2
Nicorandil Impurity 4 Dinitrate Nicorandil Impurity 4 Dinitrate 1798026-96-6 C16H17N5O5
Verapamil Impurity N Verapamil Impurity N 2086274-75-9 C33H47N3O4
Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)- Ergoline-8-carboxylic acid, 2-bromo-9,10-didehydro-6-methyl-, (8β)- 478-83-1 C16H15BrN2O2
Adefovir Impurity 6 Adefovir Impurity 6
Apremilast Impurity QY Apremilast Impurity QY
Dextrorotation lansoprazole Impurity J Dextrorotation lansoprazole Impurity J
Dextrorotation lansoprazole-N-oxide Dextrorotation lansoprazole-N-oxide
lansoprazole Impurity 23 lansoprazole Impurity 23
lansoprazole Impurity 29 lansoprazole Impurity 29
Loratadine Impurity L Loratadine Impurity L C22H23ClN2O2
meta-dyhydroxy Sugammadex sodium Impurity 1 meta-dyhydroxy Sugammadex sodium Impurity 1
Olanzapine impurity R Olanzapine impurity R C17H20N4S
Palbociclib Impurity 33 Palbociclib Impurity 33
Pramipexole Related Impurity 1 Pramipexole Related Impurity 1
Ropivacaine Impurity 37 Ropivacaine Impurity 37
Ropivacaine Impurity 42 Ropivacaine Impurity 42
Sugammadex sodium Org197339-1 Impurity Sugammadex sodium Org197339-1 Impurity
Fludarabine EP impurity G Fludarabine EP impurity G 548774-56-7 C10H12ClFN5O6P
Sitagliptin Impurity 12 Sitagliptin Impurity 12 1803026-54-1 C16H12F6N4O
Afatinib impurity 30 Afatinib impurity 30
Avibactam Impurity 45 Avibactam Impurity 45 2064219-20-9 C23H46N4O6S
Butyphthalide impurity 44 Butyphthalide impurity 44 952413-01-3 C13H18O3
Cabozantinib impurity 24 Cabozantinib impurity 24
Celecoxib Impurity 18 Celecoxib Impurity 18 2271123-54-5 C11H9F3O2
Dapoxetine impurity 22 Dapoxetine impurity 22
Febuxostat Impurity 85 Febuxostat Impurity 85
Fosaprepitant Impurity NLS Fosaprepitant Impurity NLS
Irinotecan Impurity 17 HCl Irinotecan Impurity 17 HCl 1332610-75-9 C19H14N2O4
LCZ696(valsartan + sacubitril) impurity 31 LCZ696(valsartan + sacubitril) impurity 31
Lenvatinib Impurity 24 Lenvatinib Impurity 24
Lenvatinib Impurity 30 Lenvatinib Impurity 30
Regorafenib Impurity 22 Regorafenib Impurity 22
Regorafenib Impurity 28 Regorafenib Impurity 28
Sitafloxacin Impurity ZZ-C-01 Sitafloxacin Impurity ZZ-C-01
Tofacitinib Impurity 85 Tofacitinib Impurity 85 2268720-86-9 C20H24ClN5
Tofacitinib Impurity 90 Tofacitinib Impurity 90
Nintedanib Impurity M Nintedanib Impurity M
Citalopram Impurity 14 Citalopram Impurity 14 1470362-85-6 C20H23FN2O2
Eltrombopag Impurity 8 Eltrombopag Impurity 8
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